St Jude Medical Jobshttp://jobs.sjm.com2012-05-23 23:45:59.815087USAIrvineQuality Engineer Job Requisition #: AF13886 Date Posted: 05/21/2012 Category: Engineering Quality Location: Irvine - CA - 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 our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking a high caliber, hands-on experienced Quality Assurance Engineer. This position provides quality support to our EnSite product line and works closely with manufacturing. This Engineer will monitor quality on the production floor working with inspectors. This Engineer will work closely with production engineers during product development activities to ensure quality checkpoints are in place as part of the production process. Impact this role will have: • Performs process and product qualification as outlined in a validation protocol to ensure finished products meet standards. • Works closely with production engineers to ensure quality checkpoints are in place as part of the production process and that processes are clear and concise. • Assists in the implementation of changes required as a result of internal audit findings. • Assists with IQ/OQ during development stage in preparation for process implementation. • Participates on new product development cross-functional teams. • Performs material processing. • Performs statistical analysis reports on a monthly basis. Required Qualifications: • Bachelor’s degree in Electrical Engineering • 3+ years of experience in a quality assurance role within a manufacturing environment • Experience with different types of testing including analytical testing, performance testing, design verification testing, material testing, and chemistry • Knowledge of standards • Experience with materials testing, analytical testing, performance testing, biocompatibility testing, design verification testing • Experience supporting a manufacturing environment • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships • Organized, on-time, and detailed project management skills • Energized attitude Preferred Qualifications: • Soldering certification • Medical device experience |E-mail this position Submit Resume or C.V.2012-05-21 20:25:06United StatesSt. Jude MedicalCaliforniaAF13886CAIrvine, CA28837110http://jobs.sjm.com/xml/28837110/jobUSAIrvineSystems Engineer I Job Requisition #: AF13885 Date Posted: 05/21/2012 Category: Systems Engineering Location: Irvine - CA - 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 our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking an experienced, high caliber APD Systems Engineer I. The Advanced Process Development-Systems (APDS) group develops processes and test systems to manufacture new electronic systems for the Atrial Fibrillation Division. The group also provides ongoing product engineering support for key quality improvements and cycle time reductions. As an Engineer I, the individual will execute activities on key new product development programs and product support initiatives. Impact this role will have within the AF division: Uses engineering knowledge to participate in the development of innovative medical devices or components/subsystems in support of company’s strategic plan. Conducts process development work as part of a major project. Performs analyses to develop process specifications. Provides technical information concerning manufacturing techniques, components, and test algorithms. Completes the following activities as requested: • Conceptualize new processes and testing methods using device knowledge and innovative thinking. • Develop manufacturing assembly procedures and fixturing using mechanical, electrical, and software engineering skills. • Develop test procedures and test equipment using mechanical, electrical, and software engineering skills. • Develop, review, and challenge product and process specifications. • Create product and test equipment drawings and/or models. • Participate in pFMEA activities. • Generate IQ/OQ/PQ protocols and reports for manufacturing equipment. • Review components for reliability, performance, and standardization. • Facilitating and assembling rapid turn prototype, feasibility, and test product builds. • Ongoing support for cycle time reduction, quality improvements, and component obsolesence. • Review engineering change orders. • Run empirical and experimental analysis. • Work with outside consultants, vendors, and the medical community. • Conduct work in accordance with design control and quality system requirements. • Participate in design reviews. • Work on process design and development for new atrial fibrillation mapping, visualization, and recording systems. Required Qualifications: • Bachelor’s Degree in Engineering or Scientific discipline, advanced degree preferred. • 0-3 years experience, preferably in process development for electrical systems. • Experience with development of medical devices preferred. • CAD Experience in Solidworks and/or Altium preferred. |E-mail this position Submit Resume or C.V.2012-05-21 20:25:02United StatesSt. Jude MedicalCaliforniaAF13885CAIrvine, CA28837108http://jobs.sjm.com/xml/28837108/jobUSAIrvineAssembler - 3rd Shift Job Requisition #: AF13883 Date Posted: 05/11/2012 Category: Assembly Location: Irvine - CA - 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 our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking a talented and results-oriented Assembler. The successful candidate will be working with the assembly of high-tech cardiovascular medical devices. This may include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This is a 3rd shift position. Impacts this role will have within the AF division: • Proficient assembly and packaging of medical devices following company procedures and processes meeting or exceeding quality and production standards. Use of magnification and other equipment required to perform assigned job(s). • Understand and accurately complete necessary paperwork. • Perform general housecleaning activities. • Other duties as assigned, including training support as defined by area Group Leader. Required Qualifications: • Qualified candidates will have a High School diploma or equivalent. • Minimum of six months high tech assembly experience required, preferably in medical device industry. • Candidates with at least 4 months specific product line experience may be considered. • Must have demonstrated ability to read and understand written procedures and follow directions. • Must have a high level of attention to detail. • Must be able and willing to work overtime. |E-mail this position Submit Resume or C.V.2012-05-11 18:46:54United StatesSt. Jude MedicalCaliforniaAF13883CAIrvine, CA28634580http://jobs.sjm.com/xml/28634580/jobUSAIrvineAssembler - 2nd Shift Job Requisition #: AF13884 Date Posted: 05/11/2012 Category: Assembly Location: Irvine - CA - 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 our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking a talented and results-oriented Assembler. The successful candidate will be working with the assembly of high-tech cardiovascular medical devices. This may include detailed assembly, operation of various equipment and machinery, 100% inspection, and packaging. This is a 2nd shift position. Impacts this role will have within the AF division: • Proficient assembly and packaging of medical devices following company procedures and processes meeting or exceeding quality and production standards. Use of magnification and other equipment required to perform assigned job(s). • Understand and accurately complete necessary paperwork. • Perform general housecleaning activities. • Other duties as assigned, including training support as defined by area Group Leader. Required Qualifications: • Qualified candidates will have a High School diploma or equivalent. • Minimum of six months high tech assembly experience required, preferably in medical device industry. • Candidates with at least 4 months specific product line experience may be considered. • Must have demonstrated ability to read and understand written procedures and follow directions. • Must have a high level of attention to detail. • Must be able and willing to work overtime. |E-mail this position Submit Resume or C.V.2012-05-11 18:46:54United StatesSt. Jude MedicalCaliforniaAF13884CAIrvine, CA28634579http://jobs.sjm.com/xml/28634579/jobUSAIrvineQuality Control Inspector Job Requisition #: AF13852 Date Posted: 05/01/2012 Category: Quality Control Location: Irvine - CA - 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 our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking an experienced, high caliber, Quality Control Inspector. The successful candidate in this position will perform a wide variety of functions, including visual, functional (mechanical/electrical) and dimensional inspections of final product/component/packaging to ensure that products conforms to all specifications, drawings and procedures and be able to utilizing measuring equipment and procedures. Impact this role will have within the AF division: • Perform visual, functional (mechanical/electrical) and dimensional inspections of final product/component/packaging to ensure that products conforms to all specifications, drawings and procedures. • Work closely and cooperatively with area Supervisor or Quality Engineer to ensure quality checkpoints are in place as part of the production process and partner with quality work groups on day-to-day problem solving related to product production and process improvement. • Communicate with Quality/Manufacturing Engineering and Management on quality issues. • Practice Good Manufacturing Practices (GMPs) including documentation practices and proper gowning techniques. • Review device history records for sign-off of completion of operation and accuracy. • When applicable, initiate and complete nonconforming material reports to ensure appropriate disposition of nonconforming material. • Provide and complete required GMP, Issue resolution and task specific training. • Assist in the implementation of changes required. • Support quality inspection functions of other manufacturing cell product lines as needed. Required Qualifications: • High School diploma • Prior experience with Quality Control in a manufacturing environment. • Execute test protocols, final inspection testing under engineer supervision. • Be able to communicate ideas effectively both verbally and in writing and to facilitate change. • Working knowledge of Good Manufacturing Practices (GMPs). • Excellent interpersonal and communication skills are essential for success. • Must be able to work well with others in a team environment and have a hands-on approach to problem solving. • Must possess the ability to handle multiple tasks with attention to detail. • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • Experience in an Inspector role. • Prior experience in the medical device industry. |E-mail this position Submit Resume or C.V.2012-05-01 19:14:51United StatesSt. Jude MedicalCaliforniaAF13852CAIrvine, CA28305015http://jobs.sjm.com/xml/28305015/jobUSAIrvineProduct Development Engineer II Job Requisition #: AF13842 Date Posted: 04/17/2012 Category: Engineering Location: Irvine - CA - 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 our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking an experienced, high caliber, Product Development Engineer II to develop design concepts of disposable medical devices for the treatment of cardiac arrhythmias. The engineer will partner with other product development Engineers and perform the necessary developments and validations to advance the state of art designs of products requested from the customers. The engineer will create design history file documentation and write protocols and test reports for verification and validation testing. The engineer will also identify key design concepts for improving sub-assembly and final assembly of finished catheters. In addition, the engineer will assign prototyping and testing tasks to the R&D technicians to maintain continuous flow of product delivery to Advanced Manufacturing and Production. Impact this role will have within the AF division: • Communicates and demonstrates feasibility to customers and management focusing on treatment of cardiac arrhythmias. Evaluation of technologies should be based on the ability of the technology to provide a clinical utility to the user. • Independently focuses on design improvements having merit and meeting the robustness of design for manufacturability. • Maintains workflow with all of the necessary processes pertaining to Change Requests to effectively reduce multiple design changes that tend to slow the progression of each project. • Addresses issues and communicates with interdepartmental personnel to foster a complete understanding of the project scope and direction before releasing the design to the next responsible individual or department. • Identifies key attributes for advancing the state of the art of related products to the core business. Required Qualifications: • Requires Bachelor’s degree • 3+ years as a product development engineer with experience in all aspects of development activity of disposable medical devices • Demonstrated success in bringing new products from concept to market • Knowledge of design controls as well as FDA Quality System Requirements • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization • Organized, on-time, and detailed project management skills • Energized attitude Preferred Qualifications: • Bachelor’s degree in Mechanical Engineering • Familiar with ISO standards, GMP and GLP procedures. • Have high level understanding of design analysis and root cause failure analysis procedures for disposable catheters, preferably electrophysiology catheters. • Experience with design and processes involved in catheter manufacturing including extrusion and injection molding. St. Jude Medical is an equal opportunity employer. |E-mail this position Submit Resume or C.V.2012-04-17 18:48:09United StatesSt. Jude MedicalCaliforniaAF13842CAIrvine, CA27948908http://jobs.sjm.com/xml/27948908/jobUSAIrvineSenior Electrical Engineer Job Requisition #: AF13804 Date Posted: 04/05/2012 Category: Electrical Engineering Advanced Process Development Location: Irvine - CA - 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 our Atrial Fibrillation Division in Irvine, CA. Job Overview The Advanced Process Development-Systems (APDS) group in AFD-Irvine involves with new product development, product engineering support and develops processes and test systems for instrumentation manufacturing. We are seeking a talented, hands-on Senior Electrical Engineer to provide technical leadership on key projects, provide solutions that meet market and customer needs along with regulatory requirements. Plan, and organize engineering projects to meet company objectives for design, new product development and improvement of existing product lines – from project approval through volume production. Essential Functions: • Serve as technical leader for new product development and product improvement projects. • Provide in-depth analysis and innovative technical solutions. • Maintain and develop expertise on current technology, and apply technology to new product development. • Collaborate with PD (product development) Engineering, Manufacturing and other departments to provide design, development testing and deployment of projects. • Plan and organize projects to ensure timely and effective delivery into production and overall completion. • Manage multiple, parallel projects using formal project planning techniques. • Coordinate and lead project meetings with department representatives to ensure each project is meeting timeline. • Confer with project team members to address work procedure or project status questions, and resolve technical issues/complaints. Required Qualifications • BS in Electrical or Bioengineering and minimum 6 years relevant experience or MS in Electrical or Bioengineering and minimum 3 years relevant experience. • 5 or more years of direct experience in medical device industry. • Experienced in system design, embedded system design, analog and digital circuit design, embedded software. Knowledge of real time operating system. • Demonstrated strong technical and analytical/problem solving skills. • Write test protocols, reports and specifications. Perform bench and design V&V testing. • Experience with engineering change orders, documentation needs, protocol and report writing. Familiarity with d/pFMEA, DOE and QSR design control. • Strong verbal and written communication skills; ability to effectively communicate ideas to facilitate change at all levels of the organization. • Experienced with EE CAD tools. Preferred Qualifications • Adhere to medical device design control processes. Generate and maintain DHF (Design History File) during product development as required by project. • Experience with managing engineering projects and/or formal project management training • System architecture design experience. • Familiar with IEC standard; familiar with AAMI standards; familiar with system electrical safety requirements and EMI/EMC requirements. • Development of IQ/OQ/PQ protocols and reports for manufacturing equipment. • Experience with a variety of manufacturing processes • Experience using Lean Sigma or other Design for Manufacturability toolset required. • Review components for reliability, performance, and standardization. • Supplier technical capability reviews in partnership with supplier quality review. • Facilitating and assembling rapid turn prototype, feasibility, and test product builds. • Ongoing support for cycle time reduction and quality improvements. • Ongoing support for component obsolescence. • Review engineering change orders. • Experience with LabView tools. |E-mail this position Submit Resume or C.V.2012-04-05 19:59:04United StatesSt. Jude MedicalCaliforniaAF13804CAIrvine, CA27668571http://jobs.sjm.com/xml/27668571/jobUSAIrvineSenior Product Dvlpmnt Engineer Job Requisition #: AF13825 Date Posted: 04/05/2012 Category: Engineering Location: Irvine - CA - 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 our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking a high caliber, experienced, hands-on Engineer that is innovative in driving new product development for AFD. This is a high profile position that will partner with product development engineers to develop new Catheter design concepts, associated test method development and early process characterizations. Impact this role will have: • Develops new test methods and procedures for the characterization of early phase catheter design concepts, as well as device verification testing. • Leads in the development and validation of standardized variable data collection test methods in both discovery and design control environments • Collects, reduces, analyzes and presents empirically derived data using DOE, ANOVA and other statistical tools. • Assists the development of design performance simulation, both closed form & computer aided numerical modeling techniques. • Establishes the definition of material performance and defines the load case required, to understand and develop a match to clinical scenarios. Required Qualifications: • BS in Mechanical, Materials or Biomedical Engineering • 6+ years of product development (R&D) experience • Direct catheter experience. • Familiarity with CAD and FEA software (e.g. ProE, Abacus, ANSYS etc.). • Process development experience – process identification and process characterization. • Demonstrable experience using MiniTab statistical analysis software. • Demonstrated ability to lead technical projects meeting established deliverables. • Direct experience leading and/or performing failure analysis. • Effective communication skills and experience working with cross functional teams. • Excellent documentation writing skills; clear and concise using objective evidence and language. • Superior organizational skills including project management aptitude. • Energized attitude |E-mail this position Submit Resume or C.V.2012-04-05 19:58:22United StatesSt. Jude MedicalCaliforniaAF13825CAIrvine, CA27668542http://jobs.sjm.com/xml/27668542/jobUSAIrvinePrincipal Product Development Engineer Job Requisition #: AF13821 Date Posted: 03/26/2012 Category: Engineering Location: Irvine - CA - 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 our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking a high caliber, experienced, leading hands-on Engineer that is innovative in driving new product development for AFD. This is a high profile position that will partner with product development engineers to develop new Catheter design concepts, associated test method development and early process characterizations. Impact this role will have: • Leads the design and process development of new products • Represents Product Development on cross functional product development teams • Applies engineering/ design/ process knowledge to the development of new products • Manages engineering and technician support assigned to the project • Develops schedules and timelines for project work and tracks to and updates • Authors designs control documentation including specifications, requirements, reports, and protocols • Provides engineering, design and technical support of products introduced currently in release. Required Qualifications: • BS in Mechanical or Biomedical Engineering • 10 + years experience in catheter based product design/ R&D in Medical Device industry • 3+ years project leadership or management experience • Demonstrated knowledge of successful process development- process identification and process characterization • Track record of successful product transfer from Product Development to Manufacturing • Demonstrated ability to work with manufacturing to improve products and processes to increase yield(s) • Experience with medical design from initial concept generation to manufacturing • Strong analytical reasoning • Experience working within medical device regulatory systems (FDA Design Controls, ISO9001, GMP) • Polished communicator • Excellent documentation writing skills; clear and concise using objective evidence and language • Excellent reputation for building relationships • Organized, on-time, and detailed skills • Energized attitude Preferred Qualifications: • MathCAD experience • Knowledge of electrophysiology • Working knowledge of statistics • Experience w/Cardiac anatomy • Tissue ablation • Catheter design To learn more, visit our web site at www.sjm.com. St. Jude Medical is an equal opportunity employer. |E-mail this position Submit Resume or C.V.2012-03-26 20:58:00United StatesSt. Jude MedicalCaliforniaAF13821CAIrvine, CA27398973http://jobs.sjm.com/xml/27398973/jobUSAIrvineSenior Design Quality Engineer Job Requisition #: AF13715 Date Posted: 03/13/2012 Category: Engineering Location: Irvine - CA - 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 our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking an experienced, high caliber, Design Quality Assurance Engineer to join our organization. This Senior Engineer partners with employees on cross functional teams focused on new product development. This DQE leads and ensures new product designs are in compliance in the following critical areas- marketing/user requirements, technical/engineering specifications, technical drawings, design verification and design validation test protocols and reports, risk analyses and reports, test method validations, equipment qualifications, and manufacturing procedures. Impact this role will have within the AF division: • Provide guidance to support completion of new product development quality deliverables: risk analyses and reports including FMEAs and Fault Tree Analyses; quality, shelf life, packaging, biocompatibility, and sterility assessments and plans; others. • Review and provide guidance on creation of new product development process deliverables, ensuring deliverables meet internal requirements: marketing/user requirements, technical/engineering specifications, technical drawings, design verification and validation test protocols and reports, risk analyses and reports, test method validations, equipment qualifications, manufacturing procedures, etc.. Work with process owners to develop procedures and work instructions for design control and new product development. • Ensure new product design compliance to internal Standard Operating Procedures (SOPs) and International Standards Organization 13485 and 21Code of Federal Regulations Part 820 Quality System Regulations. Ensure internal SOP compliance to external regulations. • Support and lead failure investigations including root cause analysis, correction, corrective/preventive actions, Design History File updates. Subject Matter Expert for failure investigation techniques and documentation. • Communicate any quality-related issues to Quality Management, propose and lead implementation of appropriate corrective actions. Prepare corrective action implementation project plan and schedule. • Subject Matter Expert for evaluation of effectiveness and safety of new product designs using understanding of the physiology and electrical systems of the human heart (including phenomena associated with atrial fibrillation), atrial fibrillation-related Electrophysiology (EP) lab procedures and equipment use cases, and knowledge of the design, function, and typical failure modes of devices manufactured by SJM-AFD. Required Qualifications: • B.S. Engineering degree. • Extensive product and process validation experience. • Strong written and oral communication skills. • Successful track record of being organized, ability to prioritize, and working both independently and in teams. • Experience with new product development process through project completion under 21CFR Part 820 or Medical Device Directive regulations. • Understand and able to provide guidance regarding statistical decision-making (ANOVA, hypothesis testing, goodness-of-fit, etc.), data analysis (data types, accuracy vs. precision, mean/range/standard deviation), statistically sound sampling plans and acceptance criteria, measurement system analysis (Gauge R&R, capability), risk/hazard analysis techniques (FMEA/FMECA, FTA). • 7+ years of QA experience within the medical device industry. • Experience with MS Word, MS Excel, MS Visio, Minitab. • Great reputation for leading and driving change on multiple projects. • Polished communicator- written documentation and oral presentations/ discussions/ meetings. • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. • Ability to influence others without authority. Preferred Qualifications: • Preferred degrees are related to medical devices, such as Biomedical or Electrical Engineering degree. • CQE, CQA certification. To learn more, visit our web site at www.sjm.com St. Jude Medical is an equal opportunity employer. |E-mail this position Submit Resume or C.V.2012-03-13 23:44:27United StatesSt. Jude MedicalCaliforniaAF13715CAIrvine, CA27117043http://jobs.sjm.com/xml/27117043/jobUSAIrvineManufacturing Manager II Job Requisition #: AF13629 Date Posted: 11/23/2011 Category: Manufacturing Location: Irvine - CA - 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 our Atrial Fibrillation Division in Irvine, CA. Job Overview We are seeking an experienced, high caliber, talented and results-oriented Manufacturing Manager II to join our Irvine, California facility. The successful candidate will manage and lead the production and distribution activities for a three shift manufacturing facility. Impact this role will have within the AF division: • Responsible for hiring, training and retaining a diverse, highly qualified staff and for providing career coaching, growth and personal development. • Accountable for the development of staff: critiques, instructs, mentors, evaluates and coaches to maintain current industry standards for field of responsibility and that safety requirements for laboratories and chemical handling are met within department. • Maintains a strong customer focus. • Models optimum leadership competencies to inspire an energized, empowered and accountable work force. • Develops/monitors/controls budgets for multiple assigned areas and meets area financial objectives. • Cooperatively develops annual operational build and financial plans and over achievement/continuous improvement plans. • Determines resources to meet project objectives and manage budgets. • Forecasts and reports resource consumption area activity, performance and financial trends. Monitor/reduce inventory levels. • Develops production plans and initiates activity to meet production demand requirements and business needs. • Leads capital improvement projects and prepares capital expenditure requirements. • Conducts feasibility studies and develops project schedules. • Provide vision, strategies and tactics to ensure sustainable competitive advantage of assigned areas. • Maintains regular, reliable, and predictable attendance. • Complies with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. • Performs other essential functions and responsibilities as determined by the company from time to time. Required Qualifications: • Bachelors Degree in Business, Engineering or Sciences. • 7+ years of leadership experience in a high-volume, multi-product manufacturing environment. • Ability to learn, train, and follow good manufacturing practices (FDA/GMP's) and other applicable regulatory standards (i.e., ISO9000) and ensures operational compliance. • Solid people management skills, including demonstrated ability to coach, mentor and develop employees. • Solid communication, interpersonal, and motivational skills. • Solid knowledge, practical application, and use of Lean Principles and the commitment to those Principles. • Polished communicator- written documentation and oral presentations/ discussions/ meetings • Excellent reputation for building relationships across various levels of an organization. • Organized, on-time, and detailed project management skills. • Energized attitude. Preferred Qualifications: • Experience leading and implementing lean manufacturing/Six Sigma and change initiatives. • Medical device industry experience. • Masters Degree in Business, Engineering or Sciences. • SAP. To learn more, visit our web site at www.sjm.com. St. Jude Medical is an equal opportunity employer. |E-mail this position Submit Resume or C.V.2011-11-23 16:26:07United StatesSt. Jude MedicalCaliforniaAF13629CAIrvine, CA25029408http://jobs.sjm.com/xml/25029408/job