St Jude Medical Jobshttp://jobs.sjm.com2012-05-24 10:44:47.450318USAWestfordEngineer - Research & Development Job Requisition #: 13223 Date Posted: 05/16/2012 Category: Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Senior Applications Engineer PRIMARY DUTIES AND RESPONSIBILITIES: Lightlab Imaging, a subsidiary of St. Jude Medical, seeks a talented applications engineer to help develop the next generation of intravascular imaging systems. The successful candidate will have an external role understanding/supporting the customer and an internal role developing the new system. Externally, working with the marketing and clinical teams, they will be responsible for supporting operation of the imaging systems during preclinical and clinical investigations. As part of this effort they will look to understand the user needs and product limitations. Internally, working in the development team, they will help to merge the user needs and development realities into a finish product with a specific emphasis on the user interface, ease of use, and image processing. The job is based in Westford MA but will require significant travel (US and internationally) Additional responsibilities may include other SW development tasks EXPERIENCE & SKILL REQUIREMENTS: Degree BS/MS in Software or Biomedical Engineering with a SW or Image Processing Concentration. Experience (a combination of some of the following experiences is preferred) Clinical role in the cardiac catheterization lab Clinical or Technical experience with intravascular imaging (OCT, IVUS or FFR) Engineering Development experience in the clinical or pre-clinical setting User Interface Development Validation of medical imaging with histology Marketing Support for New Product development/introduction |E-mail this position Submit Resume or C.V.2012-05-16 19:42:26United StatesSt. Jude MedicalMassachusetts13223MAWestford, MA28738985http://jobs.sjm.com/xml/28738985/jobUSAWestfordGroup Lead - Production Job Requisition #: 12937 Date Posted: 04/30/2012 Category: Assembly Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Ensures the effective use of material, equipment and personnel in producing quality production; Responsible for ensuring inventory accuracy, cycle counts, and meeting build schedules; Essential Functions: • Manages directly the manufacture of medical device; • Ensures that quality and production goals are met; • Trains production operators on GMP, MP and retrain as needed; • Daily meeting with manufacturing operators for better communication and continuous improvement; • Organizes work schedule, Monitors performance and reports status; • Ensures PM (preventive maintenance) and Calibration stickers are up to date; • 5S audit and weekly meeting with other area value stream group-leads in a organization Other Duties: • BBSP Observation • Help with any employee needs; ( assist with training and employee ESS needs) • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Qualifications: • Prefer two years of college or equivalent experience. • Prefer one - three years experience as a group-lead in a manufacturing environment. • Must be detail oriented, self-motivated, and have good communication skills. Must have the ability to read and interpret written documentation. Desired demonstrated knowledge of LEAN manufacturing, assembly, and production technical skills, and quality practices; • Computer skills desired in excel Microsoft word and have trained SAP (S2S) software • Ability to effectively work and communicate with others is critical. • Prefer pervious training experience in a manufacturing environment. |E-mail this position Submit Resume or C.V.2012-04-30 18:49:16United StatesSt. Jude MedicalMassachusetts12937MAWestford, MA28273661http://jobs.sjm.com/xml/28273661/jobUSAWestfordTechnical Marketing Manager Job Requisition #: 13102 Date Posted: 04/26/2012 Category: Marketing Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for the management of the department's Technical Marketing function, including establishing and esuring the department's Technical objectives, product planning process and executing field related programs. Essential Functions: •Works effectively on Core Teams in support of new technology, provides support to Research and Development, and the sales force as needed to help develop new product iterations, and provides technical support. Provide Product feedback, comments and suggestions and Competitive information, and work with clinical and marketing on the development of educational modules and materials. •Partner with U.S. Sales Division and International Sales Division to determine technical customer requirements for service and support. •Establish Technical Marketing project priorities and allocate resources and workload •Be conversant with worldwide product portfolio, recommending product additions, deletions, new product ventures and field technical direction •Input to product planning, including product phase-in and phase-out •Provide support for DICOM related issues •Ensure appropriate training and education is provided to those personnel that are involved in the use or application of division products •Liaison with other departments (e.g., Quality, R&D , Legal, Operations, Marketing and Clinical Affairs) for division-wide initiatives •Prepare and manage annual department budget Qualifications: •Bachelor's degree; MBA preferred •10+ years experience •Extensive experience with Technical interface with US and global customers •Strong interpersonal and people management skills •Strong analytical and project management skills •Ability to travel up to 60% Required: •Degree in Engineering, Biological Sciences, Nursing, or a related field. •A minimum of five to seven years of relevant field service and/or clinical experience in hospital enviroment, research, or cardiology, preferably cardiac catheterization laboratory experience. •Preferred minimum of three to five years experience as a field clinical specialist or engineer. •Needs to have a working knowledge of imaging modalities. •DICOM knowledge is essential to position. •Requires demonstrated written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees, management and customers. •Documented record of delivering information that adds value to management's decision making process. •Demonstrated personal computer skills including spreadsheet, word processing, email, database management, PowerPoint and specialized applications. •Evaluation, originality and/or ingenuity required. •Ability to travel (domestic and internationally) up to 70% and to travel with minimum notice, with the potential for extended periods (up to a week). |E-mail this position Submit Resume or C.V.2012-04-26 18:12:36United StatesSt. Jude MedicalMassachusetts13102MAWestford, MA28203445http://jobs.sjm.com/xml/28203445/jobUSAWestfordSr. Engineer - Software Job Requisition #: 12961 Date Posted: 04/23/2012 Category: Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview POSITION SUMMARY: Work under the direction of principal engineers to design and develop software for the Lightlab family of cardiovascular imaging products in a FDA regulated environment. Duties include: contribute to requirements specifications and design documentation, implement and test software code, investigate and debug software problems. REQUIRED EXPERIENCE & SKILL QUALIFICATIONS: Minimum 7 years experience in software engineering, in all phases of software development development process. Expert in C++ programming language Expert in object oriented software design Experience designing and implementing real time and/or high performance systems Experience with Microsoft Windows software development environment DESIRED SKILLS: Experience designing and implementing user interfaces. Experience interfacing with hardware devices Experience with data acquisition systems Experience in medical device industry Experience in FDA (or other) regulated development environment Experience in medical imaging EDUCATIONAL QUALIFICATIONS: BS in computer science, electrical engineering or other related engineering discipline |E-mail this position Submit Resume or C.V.2012-04-23 20:19:12United StatesSt. Jude MedicalMassachusetts12961MAWestford, MA28080471http://jobs.sjm.com/xml/28080471/jobUSAWestfordSoftware Engineer - Senior Job Requisition #: 12982 Date Posted: 04/23/2012 Category: Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Intravascular Optical Coherence Tomography (IVOCT) is a new imaging modality capable of providing high resolution images of arterial vessels. The need for fast and reliable interpretation of these images is becoming increasingly important as they can provide potentially life saving information. Relying solely on human interpretation can be expensive and time consuming, not to mention prone to inconsistency and errors. We are seeking a talented individual to join our development efforts in the design and implementation of different image segmentation and characterization algorithms. As a member of our group, independent and collaborative work are both expected during the development and implementation of new algorithms. The successful candidate should be able to understand requirements, objectively analyze problems and efficiently design and implement solutions as well as clearly document his work. Requirements - Strong C/C++ skills. - Demonstrated experience with applied image processing and/or analysis. - A degree (preferably graduate degree) in Computer Science or any related area. - At least 5 years of commercial development experience (preferably on a windows platform). - Experience with SIMD CPU and/or GPU programming is a plus. - Familiarity with source control and bug tracking tools. - Good English communication skills, oral, reading and writing (should be comfortable reading scientific publications). - Ability to work both autonomously and within a team. |E-mail this position Submit Resume or C.V.2012-04-23 20:18:42United StatesSt. Jude MedicalMassachusetts12982MAWestford, MA28080448http://jobs.sjm.com/xml/28080448/jobUSAWestfordVP - R&D Job Requisition #: 12984 Date Posted: 04/23/2012 Category: Research Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview VP of R&D Position Summary: Responsible for defining strategic product goals for the division and for directing the R&D department. Establishes current and long range objectives, plans and policies. Provides guidance for the design and development of company products. Works closely with Regulatory Affairs/Quality Assurance personnel (internal or external) to determine appropriate regulations and maintain regulatory compliance. Leads the cultural development of the department to provide a positive work environment. The Vice President is also responsible for following established quality system practices. Essential Functions: •Establish the strategic direction of CVD Massachusetts R&D function to ensure new product development enhancing St. Jude's market position. •Establish product development milestones and long term strategic product plan to meet the evolving clinical and economic requirements of diverse global healthcare systems. •Represent the company as appropriate in its relationships with major customers, suppliers, competitors, government agencies, professional societies and similar groups. •Determine and monitor the department's financial requirements, ensure budget and organizational adequacy. •Identify and interface with customers to bring customer requirements to employees of St. Jude Medical. •Establishes and maintains an effective system of communications throughout the company to ensure department milestones and contributions are achieved and appropriately understood. •Plan for the development of people and maintains programs which will encourage successful future management of business. •Participate in the assessment of new technologies and companies outside of St. Jude Medical. •Contribute to the development and expansion of the Company's intellectual property assets. •Ensures quality compliance through leadership and compliance in all product development activities. •Monitor the effectiveness of the quality system as it pertains to R&D and modify/update the procedures as needed together with quality system management. Qualifications: •A four-year degree in Science or Engineering, or a field related to the medical device industry; Advanced degree preferred. •15-20+ years of experience in the medical device industry. •Successful product development and release track record of complex medical devices: Capital equipment, Catheters, Software •Experience leading and/or managing a medical device engineering team. •Experience in developing and building a company in a fast-paced, speed to market culture. •Excellent written communication skills and interpersonal skills. |E-mail this position Submit Resume or C.V.2012-04-23 20:18:15United StatesSt. Jude MedicalMassachusetts12984MAWestford, MA28080437http://jobs.sjm.com/xml/28080437/jobUSAWestfordSupervisor - Quality Job Requisition #: 12983 Date Posted: 04/23/2012 Category: Quality Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: The Quality Supervisor position is responsible for managing the daily quality inspection and QA release activites to support operations. Essential Functions: • Provide daily supervision, work direction and training to staff at multiple sites. • Develop and maintain a competent work group through effective hiring, communications, recognition, performance feedback and development. • Monitors, directs and prioritizes workload to assure customer requests and expectations are met. • Works directly with operation to support production goals and contribute to production planning for appropriate allocation of resources. • Support all facilities as necessary via training and troubleshooting document control. Contributes to establishing departmental goals and objectives. • Provide support to other departments as required. • Provide department status updates to Management. • Identify and provide solutions to improvement opportunities. • Resolve conflicts. • Motivate team to achieve results. • Foster a culture of continuous improvement. • Write monthly report to communicate status of goals and objectives to Management. • Ensure departmental compliance to procedures. • Maintain departmental procedures to ensure compliance. Other Duties: • Support divisional initiatives as defined by management, Quality Management Systems and Environmental Management systems as well as other regulatory requirements. Accountability/Supervision: • Resolve conflicts between department members and customers. • Receives monthly direction from Documentation Relationships: Describe contacts and purpose of relationships. Internal: All departments. External: Suppliers of imaging services. Equipment: • Computers, scanners, printers, copiers • Standard office software programs • ERP databases (SAP) • PDM Working Conditions: • General office environments. Physical Demands: • See ADA Factors Qualifications: • 5+ years supervisor experience • High school degree required; Bachelors degree preferred • Previous Quality inspection, technician or engineering experience required • Knowledge of FDA, GMP, and ISO 13485 • Strong communication and leadership skills • Prior medical device experience preferred • Solid communication and interpersonal skills • Be able to direct or guide departmental personnel. • Solid computer skills and report writing skills |E-mail this position Submit Resume or C.V.2012-04-23 20:18:14United StatesSt. Jude MedicalMassachusetts12983MAWestford, MA28080435http://jobs.sjm.com/xml/28080435/jobUSAWestfordEngineer Principal - Quality Job Requisition #: 13060 Date Posted: 04/20/2012 Category: Process Development Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for leading the development and maintenance of quality engineering methodologies and providing quality engineering subject matter expertise within new product development, manufacturing, or system/services support. Essential Functions: • Provides project direction, coaching, teaching, and mentoring for Quality engineering and technical team personnel. • Leads multifunctional teams in completing program directed or continuous improvement activities. • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Lead in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of CTQ parameters and specifications • Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities Other Duties: • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Accountability/Supervision:. Expected to independently and effectively make data based decisions with respect to individual and project team deliverables. Able to independently perform core team member role. Able to manage and mentor technicians and lower levels of engineering. Qualifications: • BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred • 10+ years experience • Demonstrated supervisory experience • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Demonstrates technical leadership within the department and outside the department • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-04-20 18:08:30United StatesSt. Jude MedicalMassachusetts13060MAWestford, MA28034677http://jobs.sjm.com/xml/28034677/jobUSAWestfordEngineer - Manufacturing Job Requisition #: 12985 Date Posted: 04/16/2012 Category: Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Essential Functions: List the significant/essential duties, tasks or responsibilities which employees in this position are actually required to perform. Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions. Provide guidance to operators and technicians. Additional responsibilities include: • Perform manufacturing non-conformance root cause analysis, generate non-conforming material reports and interact with the non-conforming material review board on regarding Laser Assembly Processes and components • Provide technical mentorship and support to operators • Conduct Process FMEAs and Process Validations • Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts • Coordinate the design, procurement, build and debug of tooling, machinery and test equipment Work with Product Development to ensure Design for Manufacturability Individual should: • Be innovative, resourceful, and work with minimal direction • Have excellent organization, documentation, problem solving, communication, and teamwork skills • Work effectively with cross-functional teams Other Duties: List any other important but non-essential and/or infrequent duties performed. • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Qualifications: Describe minimum education and experience, including knowledge, skills and abilities, required to successfully perform the job. List any certificates, licenses, and/or registrations required. • BS, Electrical Engineering, Physics or Optics • 5+ years manufacturing engineering experience • Solid state laser development, manufacturing and/or tuning experience • Medical device experience preferred • Strong analytical, problem solving skills |E-mail this position Submit Resume or C.V.2012-04-16 18:44:39United StatesSt. Jude MedicalMassachusetts12985MAWestford, MA27925634http://jobs.sjm.com/xml/27925634/jobUSAWestfordManager - Product Marketing Job Requisition #: 12964 Date Posted: 04/13/2012 Category: Marketing Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Essential Tasks: •Supporting Responsibility for the following product platforms on the US market: RadiAnalyzer, RadiAnalyzer Xpress, Quantien, PressureWire Receiver, PW USB Receiver (Ilumien), AO USB Receiver (Ilumien), Wi-Box, RadiView software, PhysioMon software, Accessories and cables. Develop, execute and follow-up product launch plans. Including: Forecasting, Production coordination, Regulatory coordination, Sales personnel training, MarCom material development (in conjunction with USD/MN/Uppsala), Communication strategy (in conjunction with USD/MN/Uppsala) •Extensive field presence on the US market. Establish good contacts with professionals and users. •Take part of planning and execution of product line and product training efforts (courses, workshops, etc.). •Suggest pricing of product lines and individual products. •Monitor and document the market segments in terms of competition, price movements, sales arguments and market changes. •Effectively communicate gained knowledge within the organization. •Market requirements specifications (including requirements from end user and sales organization). •Make presentations to the USD Sales organization at product launches, meetings etc. •Monitor use and implementation of existing Marcom Material within the market place. Suggest additional developments. •Be an instrumental part in the product development process and make sure that the market needs will be reflected. •Other duties as required Education and/or Experience: Extended Cathlab experience. Technical or Clinical. Clinical Sales background. |E-mail this position Submit Resume or C.V.2012-04-13 20:07:38United StatesSt. Jude MedicalMassachusetts12964MAWestford, MA27883010http://jobs.sjm.com/xml/27883010/jobUSAWestfordSr Program Management Manager Job Requisition #: 12896 Date Posted: 04/12/2012 Category: Program Management Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Provides leadership to a cross-functional team to develop and execute plans for commercialization of new products. Works through the Product Development Process from product concept through commercialization. Works cross-functionally with core team and functional managers to ensure that projects meet objectives and timelines. Provides guidance to core team members to assist in resolving conflicts and clearing barriers to maintain effective and timely progress towards project completion. Represents the core team to the organization, and reports team progress, project recommendations and issue resolution at senior staff meetings. Maintains the overall project plan and schedule for the core team to ensure project meets divisional goals. Essential Functions: • Leadership and Accountability o Overall accountability for program execution, typically new product development programs o Report team progress and recommendations and resolution at senior staff meetings o Represents the entire product development team to the organization o Provide leadership to the team by working to define clear, realistic goals. Leads by example with excellent diligence, planning, analysis, and communication o Ensure that the cross functional members work as a "team" focused on divisional goals o Provide guidance to core team members on management techniques o Identify and help clear barriers to maintain effective and timely progress • Project Management o Delegate and manage the activities of the functional core team members o Develop a "general management" understanding of the skills and tasks associated with a particular function. The team leader is not expected to be an expert with respect to all functional skills. Core team members are expected to bring those skills o Core team members are expected to manage the efforts associated with their function if applicable. Core team leaders often manage the core team members at a higher level of detail but are expected to manage at the level that is necessary o Apply the appropriate management techniques given project specific needs, risks and differences in core team member skill levels o Resolve project resource issues, such as performance problems or availability problems o Take the lead in the development and maintenance of the project IBP and project planning o Facilitate all core team meetings. Issue agendas and minutes. Track progress against the project plan, business plan, project contract, and action items. o Resolve conflicts within and outside the team o Provide input into team member reviews • Communication o Communicate frequently with all levels of the organization o Communicate with PIB members to ensure that they understand the issues, recommendations, and plans. The team should factor PIB member and functional manager opinions and experiences into the development of their plans o Clarify options and solution recommendations off-line to ensure effective PIB reviews and decision making Qualifications: • 8-10 years experience in a regulated manufacturing environment • 10+ years of cross-functional Project Management experience • Can synthesize complex business and technical aspects of large scale development programs • Excellent understanding of all of the functional skills required for the project • A relatively deep understanding of each functional area • Excellent understanding of all of the functional skills required for the project • Very high respect of all team members and senior management • Proven core team/functional leader • Drives innovation and change • Takes initiative • Can navigate the entire organization • Proven ability to work outside of a division • Open communication with team, functional mgmt, and PIB members • Effectively clarify issues and actions • Very good skills and proven ability to manage to plan and resolve issues • Proven project planning skills • Undergraduate degree in mechanical, biology, biomedical or chemical engineering (minimum) • Advanced degree in business or technology may be applicable |E-mail this position Submit Resume or C.V.2012-04-12 20:19:37United StatesSt. Jude MedicalMassachusetts12896MAWestford, MA27852679http://jobs.sjm.com/xml/27852679/jobUSAWestfordSupervisor - Medical Device - 2nd Shift Job Requisition #: 12906 Date Posted: 04/09/2012 Category: Manufacturing Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Medical device experience preferred. This 2nd shift position will be responsible for driving the process of continuous improvement and lean principles. They are responsible for their shifts' performance with respect to safety, quality, on-time delivery and cost. Essential Functions: • Accountable for shift's safety, quality, on-time delivery, and cost performance. • Drive continuous improvement efforts to improve metric performance. • Promote safety and ensure a safe work environment and safe work habits. • Maintain high level of visibility with production staff. Use hands-on approach to communicate daily and involve production staff in problem solving. • Develop a high performance work team with high levels of worker morale, satisfaction, and performance. • Create and maintain a respectful work environment by listening, seeking facts to support decisions, managing one's own reactions, and addressing unacceptable behavior. • Help production staff succeed through performance management. Provide coaching and performance communication to support development. • Review general status of production schedules to identify and resolve problems. • Ensure the desired product quality levels are achieved through use of standard work and training to those standards, training in operation and inspection techniques, and use of tools/data. • Support and implement new, customer-focused processes in accordance with lean principles and practices. Provide training and coaching to improve standard work, work center organization (5S), and housekeeping. Actively provide change leadership as required. • Support and foster an environment of continuous improvement by encouraging production staff to challenge existing processes and implement solutions that enhance the overall effectiveness of the operation. • Ensure adherence to all ISO and FDA quality regulations. • Support production staff in understanding company policies and practices. • Maintain time and production records. • Take notice of process related problems and support production staff in taking corrective action to improve the overall performance of the team. • Communicate with and listen to production staff on a daily basis regarding work team performance, strategic initiatives, policy changes, safety, quality, etc. • Communicate with other supervisors and appropriate personnel regarding equipment, safety, work center schedules, company policies and practices, performance improvement plans, etc. • Visionary in long range value stream strategy • Contribute to annual budgeting process • Identify, pursue and implement system/operational level improvements • Drive culture changes with initiatives such as 5S, SMED, OEE, OLE and DMAIC • Interview candidates for Value Stream and provide hiring decision for temp and regular positions. Accountability/Supervision: Assignments are received in task oriented terms. Provides direction to subordinates using established policies and precedents. Work is reviewed for soundness of judgment and overall quality and efficiency. Qualifications: • 5 -7 years of solid experience in a manufacturing operation. • B.A or B.S. degree preferred. • Commitment to implementing and achieving safety, quality, customers service and cost goals by coaching and training associates. • Previous experience in a manufacturing operation with demonstrated ability to acquire and apply manufacturing principles a plus. • Demonstrated coaching skills. • Solid knowledge, practical application, and use of Lean Principles and the commitment to those Principles. • Excellent communication skills. • Demonstrated ability to work with and motivate people. |E-mail this position Submit Resume or C.V.2012-04-10 02:03:03United StatesSt. Jude MedicalMassachusetts12906MAWestford, MA27772867http://jobs.sjm.com/xml/27772867/jobUSAWestfordTechnician - Quality Job Requisition #: 12659 Date Posted: 04/05/2012 Category: Quality Assurance Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for performing QA release of manufacturing related documentation in compliance to established requirements. Essential Functions: • Perform product documentation inspections against specification • Perform product documentation inspections against procedural and compliance requirements • Reconciliation of production data against documented nonconformances as appropriate • Issue nonconforming reports and assist in the resolution of nonconformances • Initiate related documentation changes • Collect data, summarize, analyze, perform basic statistical analysis on, and document results Qualifications: • High School degree required; 2 year technical degree preferred • 4 years minimum experience in manufacturing • 2 year experience in quality preferred • Strong understanding of manufacturing documentation (routing /travelers) and non conforming material reports • Knowledge of Quality Systems, FDA regulations and ISO 13485 • Good communication skills • Strong computer skills, including data analysis and report writing skills • Prior medical device experience a must |E-mail this position Submit Resume or C.V.2012-04-05 19:58:32United StatesSt. Jude MedicalMassachusetts12659MAWestford, MA27668551http://jobs.sjm.com/xml/27668551/jobUSAWestfordPlanner Job Requisition #: 12695 Date Posted: 03/30/2012 Category: Logistics Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Responsible for developing and maintaining top level manufacturing build plans, for existing and new products, that meet defined service level and inventory targets for the division Essential Functions: • Global Sales & Operations Planning process preparation and facilitation, including interface with Marketing, Sales, Production, Accounting, and other operations groups that are part of this process • Clearly communicate agreed upon production quantities and mix to Production and other Operations groups. • Zero backorder goal – when backorder exists full responsibility for backorder management, status, prioritization, communication • Production Plan attainment reporting and communication, including holding Operations accountable weekly to S&OP agreed upon production plans and notifying Accounting of variances to plan • Set and maintain appropriate inventory levels that meet service level objectives to customers balanced with divisional DIOH (Days Inventory On Hand) goals. • Plan new product introductions and phase outs to achieve planned launch dates with targeted inventory levels • Monthly inventory management of excess, obsolete, expiring inventory, including developing and implementing solutions to minimize inventory write-offs and communication with Finance on write-off potential • Proficient in ERP system functionality to perform job-including driving S&OP agreed upon plans thru MRP to Production for build plans or Purchasing for raw material planning Qualifications: • Bachelor Degree required • APICS or other Planning related certifications preferred. • Minimum 3 years experience in Planning function • Medical Device experience preferred. • Experience with SAP preferred. |E-mail this position Submit Resume or C.V.2012-03-31 03:43:29United StatesSt. Jude MedicalMassachusetts12695MAWestford, MA27532237http://jobs.sjm.com/xml/27532237/jobUSAWestfordEngineer - Quality Job Requisition #: 12635 Date Posted: 03/30/2012 Category: Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. Essential Functions: • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of CTQ parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 2-5 years experience • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience preferred • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-03-31 03:43:28United StatesSt. Jude MedicalMassachusetts12635MAWestford, MA27532236http://jobs.sjm.com/xml/27532236/jobUSAWestfordManager - Commodity Job Requisition #: 12693 Date Posted: 03/30/2012 Category: Purchasing Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for setting and executing procurement strategies for goods and services required within the Division. In conjunction with supporting internal business areas and projects, identifies opportunities for cost reduction, develops and executes strategies to achieve them. Duties and Responsibilities: • Implement sourcing strategies to support objectives in the area of direct commodities (electronics, optics and plastics), providing the division competitive advantage in the areas of materials, supplies, and services • Locate, analyze and develop a consolidated supplier base to meet current and future commodity needs • Negotiate and manage contracts/agreements for assigned commodities • Help implement and train new ERP system (SAP) • Maintains and promotes sound relationships with suppliers and business community • Support projects to assure all procurement activities are performed as required. • Create and maintain mutually beneficial long-term partnerships with suppliers to foster feedback and continuous improvement. This includes driving continuous improvements with the supplier base. • Develop cross-functional teams to understand division-wide needs and evaluate suppliers • Manage suppliers, cost, quality, and delivery performance. Understand, track, and forecast the key cost drivers and market factors for assigned commodities Education and Experience: • Minimum of 8 years of progressive materials/procurement experience • Excellent verbal and written communication skills • Advanced knowledge of procurement principles • BA/BS in Business, Supply Chain, Finance or equivalent • Proven ability to lead, influence and motivate others |E-mail this position Submit Resume or C.V.2012-03-31 03:43:18United StatesSt. Jude MedicalMassachusetts12693MAWestford, MA27532230http://jobs.sjm.com/xml/27532230/jobUSAWestfordIntern - Strategic Business Job Requisition #: 12852 Date Posted: 03/30/2012 Category: Internship Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview The Strategic Business Intern will be responsible for leading the strategic analysis of new healthcare technology alternatives in the field of cardiology. This analysis will include review of both clinical and cost effectiveness of new technologies in a developing market. This individual will be responsible for performing the competitive assessment of a range of novel approaches leading to recommendations to the senior executive team on strategy and investment options. This highly-visible role will contribute to the development and implementation of analysis and business strategies: • Early-stage collaboration with R&D and Clinical teams to develop a health economics perspective for a set of potential new products. • Budget impact models that calculate the potential economic and clinical impact of device usage for payers and hospitals • Literature review brochures and summaries The role involves frequent interaction with various groups within St. Jude Medical including, Marketing, Clinical Research, Research & Development and Regulatory. Essential Functions: • Perform competitive and health economic analysis, to recommend strategies to drive revenue growth for the Cardiovascular Division. • Lead the development and implementation of technology strategies that will support revenue growth for Cardiovascular Division products in key global markets. • Travel as necessary in key markets including customer visits, product training classes and tradeshows. Qualifications: • Current student pursuing Master's Degree or MBA in marketing, health aconomics, or finance • Must be enrolled in the 2012 Fall Semester • 3+ years experience in marketing, health economics, consulting or financial analyst role. • Medical device experience preferred. • Excellent interpersonal, written and verbal communication skills required; must be credible with high-level audiences. Assignment: Summer Internship Please Note: No housing, transportation or relocation allowance provided. |E-mail this position Submit Resume or C.V.2012-03-31 03:43:04United StatesSt. Jude MedicalMassachusetts12852MAWestford, MA27532224http://jobs.sjm.com/xml/27532224/jobUSAWestfordTechnician - Process Development Job Requisition #: 12658 Date Posted: 03/30/2012 Category: Process Development Technician Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Work with Process Development engineers to develop manufacturing systems that include equipment and methods of using the equipment, measurement, analysis and control of the process variables. Essential Functions: •Develop, implement and test new processes and tooling. •Analyze and improve existing manufacturing processes. •Facilitate process development decision making using computer skills for design and analysis (SPC, Statistical Analysis) •Write and prepare technical reports, qualifications and validations •Manage business process compliance through process validation, equipment qualification, document control and equipment maintenance. •Maintain materials, tools and facilities necessary for production activities. •Understand work environment issues such as OSHA regulations, FDA Quality Systems regulations and ISO requirements. •Develop new manufacturing and design technologies by staying current in areas of focus. Qualifications: •2 year technical degree preferred •5+ years technician experience •General manufacturing processing knowledge •Solid processing equipment troubleshooting and qualification skills required •Solid data compilation and analysis skills required •Solid problem solving and organization skills required •Solid interpersonal and communication skills required |E-mail this position Submit Resume or C.V.2012-03-31 03:42:54United StatesSt. Jude MedicalMassachusetts12658MAWestford, MA27532217http://jobs.sjm.com/xml/27532217/jobUSAWestfordEngineer Sr- Process Development Job Requisition #: 12591 Date Posted: 03/30/2012 Category: Process Development Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Performs analyses to develop design specifications and performance requirements. Provides technical information concerning manufacturing or processing techniques, materials, properties and process (advantages/limitations) engineering planning. Selects techniques to solve problems and make sound design recommendations. Essential Functions: List the significant/essential duties, tasks or responsibilities which employees in this position are actually required to perform. • Establishes processes based on product specifications. • Evaluates process and design alternatives based on design for manufacturability” principles. • Understands principles of Cost of Goods Sold”. • Manages program compliance with Quality Control” requirements (i.e. Design Control, Process validation etc.). • Understands IP issues relative to processes being developed. • Maintains knowledge of new developments in manufacturing and design technologies. • Understand work environment issues (i.e. OSHA regulations, etc.) • May supervise or provide work direction to other engineers and technicians • May lead or serve as member on cross-functional project teams Qualifications: • BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred • 10+ years manufacturing engineering experience • Experience designing and testing medical devices required • Experience developing manufacturing processes and technologies and designing for manufacturability required • Previous project management and people management experience required |E-mail this position Submit Resume or C.V.2012-03-31 03:42:39United StatesSt. Jude MedicalMassachusetts12591MAWestford, MA27532210http://jobs.sjm.com/xml/27532210/jobUSAWestfordTechnician - Quality Job Requisition #: 12516 Date Posted: 03/28/2012 Category: Quality Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Briefly state the main purpose and scope of the position. This position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support. Essential Functions: List the significant/essential duties, tasks or responsibilities which employees in this position are actually required to perform. • As required perform in-process inspection including documenting inspection and audit results. Perform final product inspections against specification and procedural requirements. • As necessary, assist in writing procedures and work instructions. • As necessary, document nonconformances and assist in the resolution of nonconformances • Initiate related documentation changes • Collect data, summarize, analyze, perform basic statistical analysis on, and document test results • As appropriate, assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and validations Other Duties: • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Qualifications: • 2 year technical degree required • 3-5 years experience working with supporting Quality Engineering including NCMR. • Previous experience in assisting with validations & qualifications, Gage R&R, calibration, test methods, and NCMR dispositioning • Working knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements preferred • Experience with hand tools, gages, pressure and force gage testing, and fixture design • Experience with fiber optic technology • Experience with ESD sensitize components/assembly • Training in blueprint reading and experience with sampling techniques • Good communication and computer skills, including data analysis and report writing skills • Prior medical device experience preferred • Solid computer skills in both Microsoft, Excel, Word and PowerPoint • Solid communication and interpersonal skills. • Solid data management experience. • ASQ CQT certification or equivalent preferred |E-mail this position Submit Resume or C.V.2012-03-28 20:56:15United StatesSt. Jude MedicalMassachusetts12516MAWestford, MA27463346http://jobs.sjm.com/xml/27463346/jobUSAWestfordTechnician - Maintenance Job Requisition #: 12602 Date Posted: 03/19/2012 Category: Manufacturing Technician Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Provide manufacturing support to production operators, engineering, and quality departments in a team environment. Essential Functions: •Identify, analyze, and implement manufacturing improvements (e.g., processes, yields, and productivity) •Test/troubleshoot manufacturing processes and equipment •Modify existing and develop new tooling and fixtures •Summarize, analyze, and provide recommendations from test results •Assist in writing technical reports by capturing experiemental results and demonstrating technical writing skills •Support new product introductions •Support process validation activities for continuing production and for new product •introductions •Set-up production processes using established procedures and processes Qualifications: •2 year technical degree preferred •5+ years experience, preferably in medical device industry •Demonstrated experience in molding, tooling, troubleshooting equipment, and performing machine and process set-ups •Experience in GMP, ISO, and FDA controlled environments preferred •Proficient computer, data analysis and report writing skills |E-mail this position Submit Resume or C.V.2012-03-19 18:32:35United StatesSt. Jude MedicalMassachusetts12602MAWestford, MA27237705http://jobs.sjm.com/xml/27237705/jobUSAWestfordEngineer - Packaging Job Requisition #: 12612 Date Posted: 03/19/2012 Category: Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: Support packaging and labeling processes for established product lines. Develop packaging and labeling for new products. Essential Functions: •Select, procure, install, and validate packaging and labeling equipment •Conduct Process FMEAs •Identify and implement packaging/labeling process improvement projects •Design, develop and test a wide variety of packaging used for the protection, display, and handling of products •Determine packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering •Design package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques •Responsibilities may include documentation management and an understanding of Good Manufacturing Practices (GMPs) •Creation and management of change requests within the document control system (currently Windchill) •May supervise or provide work direction to other engineers and technicians •May lead or serve as member of cross-functional project teams Qualifications: •Packaging Engineering or Mechanical Engineering degree •5+ years experience in packaging or material handling •Medical device experience preferred •Understanding of FDA, GMP, and ISO guidelines •Experience with equipment process validation principles as well as engineering documentation practices and statistical process control •Requires ability to be innovative, resourceful, and work with minimal direction •Requires excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams |E-mail this position Submit Resume or C.V.2012-03-19 18:32:33United StatesSt. Jude MedicalMassachusetts12612MAWestford, MA27237703http://jobs.sjm.com/xml/27237703/jobUSAWestfordEngineer - Manufacturing Job Requisition #: 12599 Date Posted: 03/19/2012 Category: Manufacturing Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position will design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality. Essential Functions: Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions. Provide guidance to other engineers and technicians. Additional responsibilities include: •Provide technical mentorship to engineers and technicians •Conduct Process FMEAs and Process Validations •Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts •Coordinate the design, procurement, build and debug of tooling, machinery and test equipment Qualifications: •Mechanical, Chemical or any engineering or technical degree required, or equivalent experience •5+ years manufacturing engineering experience •Medical device experience required •International manufacturing experience preferred •Strong analytical, problem solving and project management skills •Demonstrated leadership capability in team settings •Six Sigma certification preferred •25% travel required |E-mail this position Submit Resume or C.V.2012-03-19 18:32:21United StatesSt. Jude MedicalMassachusetts12599MAWestford, MA27237694http://jobs.sjm.com/xml/27237694/jobUSAWestfordService Manager Job Requisition #: 12661 Date Posted: 03/12/2012 Category: Operations Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview The Manager of Service is responsible for a wide range of activities required for the introduction, installation and maintenance of OCT systems. Essential Functions: • Lead the refurbishment and repair of returned product for OCT and FFR, including tools, calibration and testing equipment and processes. • Identify failure trends and associated root cause and statistical analysis and communicating this to the rest of the organization. • Creating demand plan for services, work with manufacturing and quality to ensure timely product flow. • Establishing and staffing the service organization, training and departmental budget management. • Interfaces with USD and ID field service functions and Engineering regarding repair issues • Champions and enables methodologies of continuous process improvement including defining and reporting departmental performance metrics. • Assists Regulatory throughout the process of complaint handling related to CVD capital equipment and peripherals. • Represents services in a cross-functional capacity while interfacing quality assurance and sustaining engineering groups. • Oversees content development and manages distribution of all technical documents including Work Instructions, Technical Bulletins, IFU's, Software Release Notes, Service Manuals, etc. • Works in conjunction with worldwide Capital Services (US, Europe, and Japan) in the planning and execution of system upgrades, software releases, field corrective actions, and other planned service events. • Collaborates with Engineering and Marketing on special projects related to new product releases and next generation products. • Works in conjunction with R&D in design for serviceability projects, including systems integration, networking, and remote connectivity. • Represents and coordinates advanced technical and applications support at the product divisional level by enabling collaboration with engineering. • Manages in-house product training and education programs related to capital equipment servicing for new hire and continuing education. • Monitors and maintains refurbished materials stock including asset management of the demo/eval systems fleet. • Coordinates and manages planned maintenance and other serviceability of all SJM owned systems that are installed in-house. • Clearly communicate expectations and goals to employees Qualifications: • B.S. in engineering or equivalent • 10 years of hands-on field service experience • 5+ years experience with software-based, complex electro-mechanical medical devices • 3 to 5 years product service management experience • Excellent organizational, communications and troubleshooting skills • Experience managing direct reports and contractors in a field service environment • Familiarity with QSR and ISO13485 is desirable |E-mail this position Submit Resume or C.V.2012-03-12 19:08:46United StatesSt. Jude MedicalMassachusetts12661MAWestford, MA27084724http://jobs.sjm.com/xml/27084724/jobUSAWestfordSpecialist - Regulatory Affairs Job Requisition #: 12581 Date Posted: 03/02/2012 Category: Regulatory Affairs Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position ensures products and procedures comply with regulatory agencies specifications Essential Functions: • Prepare 510(k) regulatory applications and 510(k) letters to file to secure/maintain marketing approvals. • Prepare PMA supplements for device or manufacturing changes. • Prepare new product Design Dossiers for submission to Notified Bodies and Health Canada. • Prepare appropriate documentation for renewing CE mark certification. • Prepare appropriate documentation for annual renewals submitted to Health Canada. • Prepare Technical Files for product s with self certified CE Marks. • Update Technical Files on annual basis. • Review device labeling and advertising materials for compliance with FDA submissions and applicable regulations. • Act as a core member on development teams, providing RA guidance, and project regulatory assessments. • Interface directly with FDA, Notified Bodies and Health Canada. • Communicate and coordinate regulatory activities with other departments. • Review of product and manufacturing changes for compliance with applicable regulations (Change Control). • Review of protocols and reports to support regulatory submissions. Qualifications: • BA or BS in a technical discipline. • 5+ years regulatory experience preferred • Experience with 510(k) applications, PMA supplements and US device regulations. • Experience with EU and Canadian medical device regulations and submissions. |E-mail this position Submit Resume or C.V.2012-03-03 00:53:20United StatesSt. Jude MedicalMassachusetts12581MAWestford, MA26905226http://jobs.sjm.com/xml/26905226/jobUSAWestfordEngineer - Quality Job Requisition #: 12565 Date Posted: 02/24/2012 Category: Engineering Quality Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. Essential Functions: • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of CTQ parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 2-5 years experience • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience preferred • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-02-27 23:58:45United StatesSt. Jude MedicalMassachusetts12565MAWestford, MA26798151http://jobs.sjm.com/xml/26798151/jobUSAWestfordSr. Electrical Engineer - Research & Development Job Requisition #: 12357 Date Posted: 02/23/2012 Category: Research Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Senior Electrical Engineer PRIMARY DUTIES AND RESPONSIBILITIES: We are seeking an enthusiastic, creative, and hard-working engineer with a strong theoretical background in electrical engineering, as well as demonstrated experience in instrumentation/systems development. The successful candidate will serve as an R&D engineer in a small group focused on developing the next generation of intraluminal imaging systems for cardiovascular applications. EXPERIENCE & SKILL REQUIREMENTS: • Development of opto-electronic signal processing and high-speed mixed signal/RF circuit designs. • Experience with low noise/wide bandwidth circuits, high speed A/D, D/A, µC, and switching power supply design. • Development of specifications & schematics, supervision of board layout process, management of prototype fabrication, development of test methods and performance of design qualification testing, support of production transfer including development of production test methods. QUALIFICATIONS: Required: • Bachelor's Degree in Electrical Engineering with 8+ years of experience • Experience with complex system architectures Desired: • Prior experience working in medical device development • Demonstrated technical leadership on a relevant project • Experience in Telecom, OCT, ultrasound or other imaging modalities • Experience with Altium Designer |E-mail this position Submit Resume or C.V.2012-02-24 03:31:44United StatesSt. Jude MedicalMassachusetts12357MAWestford, MA26719418http://jobs.sjm.com/xml/26719418/jobUSAWestfordEngineer II - Quality Job Requisition #: 12344 Date Posted: 02/21/2012 Category: Engineering Quality Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within remanufacturing/Service Essential Functions: • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Design and conduct experiments for process optimization and/or improvement • Appropriately document experiment plans and results, including protocol writing and reports • Lead process control and monitoring of CTQ parameters and specifications • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • Lead the investigation, resolution and prevention of product and process nonconformances • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) • Lead in the completion and maintenance of risk analysis • Work with design engineering in the completion of product verification and validation Qualifications: • BS degree in Engineering or Technical Field; advanced degree preferred • 2-5 years experience • Engineering experience and demonstrated use of Quality tools/methodologies • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 • Solid communication and interpersonal skills • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner • Advanced computer skills, including statistical/data analysis and report writing skills • Prior medical device experience preferred • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) • ASQ CQE or other certifications preferred |E-mail this position Submit Resume or C.V.2012-02-21 21:40:43United StatesSt. Jude MedicalMassachusetts12344MAWestford, MA26658112http://jobs.sjm.com/xml/26658112/jobUSAWestfordTechnical Writer Job Requisition #: 12298 Date Posted: 02/10/2012 Category: Technical Publications Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Primary Responsibilities: Creates, develops, organizes, plans, writes, illustrates, and edits operational, maintenance, and other electronic or printed publications for company products. Researches engineering schematics, technical design specifications, diagrams, and specifications with design engineers, users, and other staff. References hands-on experience with the equipment. Coordinates the layout and organization of manuals. Acquires and organizes basic source material, including applicable specifications, engineering specifications and drawings. May document processes and specifications. Recommends effective formats and produces products that conform to company standards. Know Software Although the software will vary, technical writers will need to be familiar with software. At a minimum, they will use word processing software such as Microsoft Word. The second most common tool is desktop publishing software such as In Design or Quark. Image editing tools such as Photoshop and Illustrator are also important. Gather Technical Information Although technical writers may not have an understanding of the technical information in the company, they must be able to research this information and communicate it appropriately to their intended audience. Interact with Subject Matter Experts Technical writers work closely with subject matter experts, such as engineers, to ensure accurate information in the documentation and to give appropriate feedback concerning product improvements. Lay Out Documents Must have an understanding of design principles to lay out the documents in an appealing way. May assist and/or provide limited support to others creating documents in the company. EXPERIENCE & SKILL REQUIREMENTS: •Bachelor’s degree and 3+ years of experience •Develops documentation to resolve complex problems very often requiring creativity • Write procedures, help menus, or describe interface interactions • Prior work with Language translations • Framemaker experience • Candidate must be able to work independently or in a team. • Previous experience in a medical device company preferred • Good organizational and follow-up skills • Ability to interface with technical groups in the organization |E-mail this position Submit Resume or C.V.2012-02-10 23:21:59United StatesSt. Jude MedicalMassachusetts12298MAWestford, MA26467969http://jobs.sjm.com/xml/26467969/jobUSAWestfordMicrobiologist Job Requisition #: 12330 Date Posted: 02/02/2012 Category: Microbiology Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position involves learning the application of microbiological concepts to the manufacturing process of a medical device and understanding process monitoring to maintain microbiological quality of the final device. Essential Functions: • Provides Facility Microbiological Support o Record review of routine microbiological test results o Routine release of manufactured product o Technical support for facility issues in the areas of sterilization, environmental monitoring, and microbiological methods. o Handles routine out of specification test results. o Begins understanding of data analysis of sterilization processes. o Participate in audits of sterilization, test lab, and biological product vendors. • Documentation o Ensures correct documentation linkage flow for microbiologically related documents. o Writes new or updates current microbiologically related documents. • Maintains understanding of applicable standards and applies them to qualifications and test methods. • Writes protocols and reports for qualifications for sterilization and microbiological test methods. o Writes appropriate validation protocols; performs or oversees validations for new technologies, equipment, and/or test methods; creates documentation for implementation. • Technical Training o Provides training to laboratory technicians on new equipment or new test procedures. o Provides training in the areas of sterilization validation and sterilization processes. • Other Projects as Directed by Department Manager. Qualifications: • Four year degree in microbiology or related science, or a four year degree and work in the field of microbiology. • Two to three years in a medical device, medical, pharmaceutical, food industry, or related industry (FDA controlled). • Two to three years in microbiology and/or sterilization • Person in this position demonstrates professional skills • Articulates technical concepts well • Excellent written communication |E-mail this position Submit Resume or C.V.2012-02-02 18:22:16United StatesSt. Jude MedicalMassachusetts12330MAWestford, MA26274278http://jobs.sjm.com/xml/26274278/jobUSAWestfordTraining and Development Specialist Job Requisition #: 12293 Date Posted: 01/25/2012 Category: Training Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Position Summary: This position works closely with Westford business leaders and other CVD HR training and development personnel to identify employee development needs and organizational training opportunities. Essential Functions: • Develop and implement production training assessment instruments, course content, and certifications, and maintain the certification system. • Proven experience with delivering training programs and/or workshops. • Partner with business leaders and other CVD HR team members to define and maintain accurate training requirements for Westford positions. • Oversee and maintain the Learning Management System (LMS) for Westford employees, including training records management, development and implementation of on-line courses, and system updates. • Utilize the LMS to generate training compliance reports, and partner with Westford leaders to ensure 100% completion of employee training requirements. • Partner with business leaders and other CVD HR team members to design, develop, and facilitate/deliver skills-based and other training programs as needed. • Develop learning tools and training materials using digital photography, digital video and word processing skills. • Other duties as assigned by supervisor. Qualifications: • Bachelor’s degree in Human Resource Development, Technical/Industrial Education or related field. • 4 + years in a technical training development role to include training facilitation and delivery. • Must be computer proficient with proven advanced capabilities in Microsoft Word and experience with Excel and Access databases • Must be proficient with digital camera and technical photography • Must be able to manage training development projects and create collaborative relationships with Engineering and Manufacturing work teams • Must be detail oriented, self-motivated, and have good communication skills |E-mail this position Submit Resume or C.V.2012-01-25 20:51:44United StatesSt. Jude MedicalMassachusetts12293MAWestford, MA26111041http://jobs.sjm.com/xml/26111041/jobUSAWestfordAccountant I Job Requisition #: 11964 Date Posted: 11/28/2011 Category: Accounting Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview PRIMARY DUTIES AND RESPONSIBILITIES: • Responsible for fixed asset general accounting including reconciliation of accounts. • Assists with overall analysis, reconciliation and review of other complex, key accounts. • Reconcile selected accounts to the general ledger in order to reflect accurate accounting in accordance with GAAP -Recommend appropriate correcting entries and improvements in accordance with GAAP. -Prepare monthly journal entries and work papers which require an understanding of complex accounting rules and principles. -Assists in executing the general ledger close process, implementing system enhancements and driving continuous improvements where possible. • Ensures accuracy and quality of general ledger close process and implements improvements to the close cycle whenever possible. • Assist in the facilitation of annual budgeting, quarterly forecasting, and annual strategic planning process. • Internal liaison and consultant for specific departments’ monthly analysis, budgeting, quarterly forecasting, and annual strategic planning processes. • Partner with upper management and functional management to fulfill reporting and analysis requirements. • Supports internal and external audits as required by preparing related work papers and analysis • Assists with monthly balance sheet analysis. • Special project analysis and backup support involving financial data. QUALIFICATIONS: • Bachelor’s degree in Business Administration, Accounting, Finance or equivalent experience required • 1-3+ years of previous general accounting experience or similar preferred • Strong Microsoft Office capabilities required • Ability to manage multiple tasks and priorities and work independently • SAP experience preferred • Ability to query and refine data into summarized results • Strong analytic skills and demonstrated capacity for accuracy • Ability to interact with people at all levels of the organization in a professional manner • Ability to maintain confidentiality of sensitive information • Ability to analyze processes and procedures and recommend improvements • Medical device manufacturing experience a plus |E-mail this position Submit Resume or C.V.2011-12-06 21:12:23United StatesSt. Jude MedicalMassachusetts11964MAWestford, MA25214114http://jobs.sjm.com/xml/25214114/jobUSAWestfordEngineer II, Test Job Requisition #: 11418 Date Posted: 07/19/2011 Category: Engineering Location: Westford - MA - USA About Us Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA: Job Overview Analog/Digital Engineer PRIMARY DUTIES AND RESPONSIBILITIES: Lightlab Imaging, a subsidy of St Jude Medical, seeks a talented electrical engineer to join a new product development group working on next generation imaging catheters. The successful candidate will work together with a Principal Analog Engineer as the electrical design team responsible for the performance and safety of various catheter mounted sensors. Responsibilities include designing the testing concepts based upon an understanding of the development goals and available technology, designing any necessary sensing circuitry, working with mechanical team to develop mechanical components, procurement and set-up of the overall equipment, qualification of early sensor prototypes using the equipment, and refinement of the test stations for production use. Additional responsibilities may include managing outside testing services where necessary. EXPERIENCE & SKILL REQUIREMENTS: Requirements BSEE with 5 years (MSEE with 2 years) Proficient with Network Analyzers and Oscilloscopes Strongly desired is experience in the following areas: Low Voltage 0-100Mhz Analog Circuit Design EMI suppression/shielding Medical Device Experience (especially Patient Isolation/Safety – IEC 60601) Product Performance Testing |E-mail this position Submit Resume or C.V.2011-07-19 18:40:07United StatesSt. Jude MedicalMassachusetts11418MAWestford, MA22480677http://jobs.sjm.com/xml/22480677/job