[{"country_short": "USA", "city": "Plymouth", "description": "Analyst, IT Business\nJob Requisition #: 13365\nDate Posted: 05/22/2012\nCategory: Information Technology\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nPosition Summary:\nProvides leadership and direction to and works with business customers in identifying and fulfilling their informational needs. Functions as a project leader for system analysis, design, development and implementation assignments.\n\n\nEssential Functions:\nProvides application development support and coordination primarily to the Manufacturing\nand Distribution organizations by:\n\u2022 Facilitating meetings in the business area to review business processes and identify\ninformation system requirements and/or needs.\n\u2022 Making appropriate recommendations for continuing, modifying, or abandoning\nproposed projects and/or systems based on the results of feasibility studies and/or\ncost/benefit analyses.\n\u2022 Maintaining and documenting the logical and physical data models including data flow diagrams.\n\u2022 Developing business process flows and data models required by the department methodology for new system development or for process redesign.\n\u2022 Preparing project and system documentation consistent with standards and\nprocedures outlined in the development methodologies.\nProvides project management support as a leader or member of a project team:\n\u2022 Develops project plans, work breakdown structures and task dependencies,\ncommunication plans, etc., according to the development methodologies.\n\u2022 Manages project activities and motivates members of the project team.\n\u2022 Provides updates and thorough communication to the project team, information\nsystems and the impacted business areas.\n\u2022 Coordinates the implementation of information systems with IS personnel and\nmembers of the impacted business areas.\nProvides coaching and training support:\n\u2022 Maintains proficiency in the tool sets used within the supported business areas.\n\u2022 Supports the business areas in their tool sets, including training and developing\nsubject matter experts within the supported business areas.\n\u2022 Conducts training that quickly prepares participants to use a maximum of system\nfeatures.\nMaintains relationships and communications with business and IS units:\n\u2022 Keeps informed of trends and new developments in technology to better advise management of means to accomplish business and information systems goals.\n\u2022 Understands the various business entities, their information systems developed by IS, and\nthe applications that they developed on their own.\n\u2022 Serves as a liaison between IS and the supported business areas.\n\u2022 Communicates effectively with management to enhance their understanding of the\nopportunities and limitations of information systems.\n\u2022 Provides effective written and verbal communications.\n\nQualifications:\n\u2022 This person must have excellent communication and customer service skills and strong\nleadership and team motivation skills in order to manage work that requires effective\ndelivery to internal SJM customers.\n\u2022 This includes bridging communication between technical areas and business areas\nfor a full and complete understanding of expectations.\n\u2022 Five to seven years business analyst experience or equivalent gained through a combination of formal training and progressive work experience, including project management experience.\n\u2022 Bachelor\u2019s degree in Business, Computer Science or related field is preferred.\n\u2022 MBA a plus.\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-22 19:30:31", "url": "http://jobs.sjm.com/xml/28867994/job", "country": "United States", "company": "St. Jude Medical", "title": "Analyst, IT Business", "reqid": "13365", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 28867994}, {"country_short": "USA", "city": "Plymouth", "description": "Clinical Programs Manager\nJob Requisition #: 13203\nDate Posted: 05/22/2012\nCategory: Clinical\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nJob Overview\nThe Clinical Programs Manager will manage the successful completion of all clinical programs. Will also be responsible for developing program budgets and hitting both enrollment and spending targets. Staff, manage and ensure competency of Clinical Research Associates including their knowledge and compliance with SOPs. Manage the timely development of PMA and other regulatory submissions.\n\nResponsibilities:\n\u2022 Manage the successful and timely execution of all device clinical trials\n\u2022 Responsible for the selection, training and management of all Clinical Research Associates including their training and compliance with all SOPs and associated regulations\n\u2022 Responsible for the training, initiation and management of clinical trial sites\n\u2022 Establish and manage trial budgets including enrollment targets\n\u2022 Report regularly on performance against plan including steps to overcome any shortfalls in enrollment or overages in spending\n\u2022 Participate in the design and development of new trials\n\u2022 Responsible for the timely development of clinical component of regulatory submissions including 510(k)s and PMAs including validation of the associated data analysis\n\u2022 Develop and maintain individual training programs for all staff\n\u2022 Able to assist in the drafting and development of publications based on the results of the clinical trials\n\u2022 Develop and maintain strong relationships with principal investigators at clinical trial sites\n\u2022 Ensure that St. Jude Medical is using the most current tools in the management of clinical trials\n\u2022 Travel estimated at 30%\n\nRequirements:\n\u2022 BA/BS in life sciences or nursing\n\u2022 10+ years experience in clinical research\n\u2022 5+ years experience successfully managing a team of clinical research professionals\n\u2022 3-5 years clinical research experience in medical device PREFERABLY\n\u2022 Demonstrated knowledge of and experience with GCP and all US regulations\n\u2022 Hands on experience in IDE clinical trials and the preparation of PMAs\n\u2022 Comfortable in both the clinical and business setting\n\u2022 Comfortable presenting to senior management\n\u2022 Ability to work independently and take direction from others\n\u2022 Strong work ethic\n\u2022 Excellent communication, problem-solving and organizational skills\n\u2022 Computer proficiency including Microsoft Office applications\n\nPreferred Qualifications:\n\u2022 Advanced degree in life sciences or nursing a strong plus\n\u2022 Knowledge and experience with European and Japan device clinical trials a strong plus\n\u2022 Experience in the cardiovascular therapeutic areas\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-22 19:30:08", "url": "http://jobs.sjm.com/xml/28867984/job", "country": "United States", "company": "St. Jude Medical", "title": "Clinical Programs Manager", "reqid": "13203", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 28867984}, {"country_short": "USA", "city": "Plymouth", "description": "Engineer - Process Development\nJob Requisition #: 13302\nDate Posted: 05/21/2012\nCategory: Process Development Engineering\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nPosition Description:\nA Process Engineer will provide Lean and Six Sigma manufacturing solutions and new manufacturing process technologies. Primary focus area will be new product development and supporting manufacturing as required.\n\nFocus on improving existing production lines as well as assist the transfer of new process into manufacturing utilizing lean methodologies. Utilize Process Failure Mode Effects Analysis (PFMEA) and statistical methods to analyze manufacturing processes for new product development and process optimization. Author new or revise existing engineering documentation such as manufacturing processes, inspection processes, materials specifications and drawings as required. Work closely with production to ensure that manufacturing goals are met. Author and execute IQ, OQ and PQ protocols. Author equipment specifications and write justifications for capital expenditures. Ensure good documentation practice is followed to meet quality system requirements.\n\nEducation:\nBachelor Degree in Engineering or Materials required.\n\nExperience/Skills:\n1-5 years experience in process engineering/development of regulated products (medical devices preferred).\nWorking knowledge of basic PC programs (Word, Excel, Power Point, VISIO, Access etc.).\nWorking knowledge of Design for Manufacture (DFM), FMEA, Process Validation, Project Management, Lean methodologies, DOE, SPC and Gage R&R preferred.\nExcellent data analysis and reporting skills.\nExcellent patience and communication skills.\nExperience with stainless steel and/or nitinol wire braiding preferred.\nExperience with nitinol material processing preferred.\nExperience with tool design and automation preferred.\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-21 20:24:32", "url": "http://jobs.sjm.com/xml/28837099/job", "country": "United States", "company": "St. Jude Medical", "title": "Engineer - Process Development", "reqid": "13302", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 28837099}, {"country_short": "USA", "city": "Plymouth", "description": "Engineer - Process Development\nJob Requisition #: 13243\nDate Posted: 05/16/2012\nCategory: Process Development Engineering\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nPosition Description:\nA Process Engineer will provide Lean and Six Sigma manufacturing solutions and new manufacturing process technologies. Primary focus area will be new product development and supporting manufacturing as required.\nAutonomy: Individual contributor with a moderate to high level of day-to-day work direction from their supervisor.\nWork Content: Typical projects will be focused towards individual process technologies affecting one to many products. Process Engineers will usually be members of a larger project team.\n\nJob Accountabilities:\nProcess Development /Operations:\nFocus on improving existing production lines as well as assist the transfer of new process into manufacturing utilizing lean methodologies. Utilize Process Failure Mode Effects Analysis (PFMEA) and statistical methods to analyze manufacturing processes for new product development and process optimization. Author new or revise existing engineering documentation such as manufacturing processes, inspection processes, materials specifications and drawings as required.Work closely with production to ensure that manufacturing goals are met. Author and execute IQ, OQ and PQ protocols. Author equipment specifications and write justifications for capital expenditures. Ensure good documentation practice is followed to meet quality system requirements.\n\nSupplier Responsibilities:\nMay interface with component suppliers to resolve manufacturing and quality issues.\n\nTeamwork/Leadership:\nWork effectively in a cross-functional team environment as an extended team member.\nMay provide work direction to technicians.\nMay train manufacturing personnel.May be a core team member for a small project.\n\nEducation:\nBachelor Degree in Engineering or Materials required.\n\nExperience/Skills:\n1-5 years experience in process engineering/development of regulated products (medical devices preferred).\nWorking knowledge of basic PC programs (Word, Excel, Power Point, VISIO, Access etc.).\nWorking knowledge of Design for Manufacture (DFM), FMEA, Process Validation, Project Management, Lean methodologies, DOE, SPC and Gage R&R preferred.\nExcellent data analysis and reporting skills.\nExcellent patience and communication skills.\nExperience with nitinol preferred.\nExperience with tool design, injection molding, packaging, polymer joining/reflow, heat setting, and automation preferred.\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-16 19:42:14", "url": "http://jobs.sjm.com/xml/28738978/job", "country": "United States", "company": "St. Jude Medical", "title": "Engineer - Process Development", "reqid": "13243", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 28738978}, {"country_short": "USA", "city": "Plymouth", "description": "Intern, R&D (Summer & Fall Semesters)\nJob Requisition #: 13031\nDate Posted: 05/01/2012\nCategory: Internship\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nSummary:\nAs a R&D Intern, you will provide technical engineering to support product development and transfer of innovative, minimally invasive medical products. You will work individually or with a group of engineers on the design, development, testing and documentation following in-place design control procedures. In this role you will generate the necessary documentation to convey design intent, including drawings, materials specifications, and test data to support regulatory submission of these devices.\n\nDuties and Responsibilities:\n\u2022 Construction and evaluation of prototype medical devices\n\u2022 Writing protocol and reports\n\u2022 Perform design verification and validations testing\n\u2022 Develop tooling and fixturing for testing\n\u2022 Generate/ECO engineering documentation, including drawings, materials specifications, manufacturing procedures, BOM's, inspection procedures.\n\nQualifications:\n\u2022 Current student pursuing a Mechanical or Biomedical Engineering degree, or other related engineering degree \u2013 Must be enrolled in the 2012 fall semester\n\u2022 Strong communication, record keeping and problem solving skills.\n\u2022 Demonstrated creativity and \"hands on\" prototyping skills - ability to prototype devices that have been conceptualized.\n\u2022 Working knowledge of ISO, GMP and QSR; FDA experience a plus.\n\u2022 Computer proficiency with Microsoft applications.\n\u2022 Ability to interact with a range of personalities.\n\u2022 Ability to take initiative and work independently\n\nAssignment: Full-timeSummer, continuing Part-time Fall Semester\nPlease Note: No housing, transportation or relocation allowance provided\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-09 18:01:42", "url": "http://jobs.sjm.com/xml/28574456/job", "country": "United States", "company": "St. Jude Medical", "title": "Intern, R&D (Summer & Fall Semesters)", "reqid": "13031", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 28574456}, {"country_short": "USA", "city": "Plymouth", "description": "Engineer - Research & Development\nJob Requisition #: 13134\nDate Posted: 05/08/2012\nCategory: Engineering\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nPosition Summary\nWe are seeking a high caliber, experienced, hands-on Senior Product Development Engineer that is innovative in driving new product development for our Minnesota based Cardiovascular division team. This is a high profile position that will work with a team of engineers to develop and commercialize new medical devices and delivery systems.\n\nDuties and Responsibilities:\n\u2022 Generates novel design ideas, builds prototypes,develops and refines design concepts\n\u2022 Generates test data and performs analysis to make design decisions\n\u2022 Works with suppliers and customers\n\u2022 Develops design specifications based on customer feedback and intended clinical use\n\u2022 Develops and refines test methods and models\n\u2022 Plans and executes design characterization, verification, and validation builds and testing\n\u2022 Generates and manages design documentation\n\nTechnologies:\n\u2022Biocompatible material selection for delivery systems and implants\n\u2022Bioprosthetic implants\n\u2022Mechanical design of biocompatible metals and plastics\n\u2022Machining\n\u2022Molding\n\u2022Nitonol\n\u2022Extrusion\n\u2022Thermoforming\n\u2022Packaging and Sterilization\n\nQualifications:\n\u2022 Bachelor's degree in Mechanical or Biomedical Engineering\n\u2022 5+ years of product development (R&D) experience\n\u2022 5+ years of medical device development experience\n\u2022 Endovascular device and delivery system design experience\n\u2022 Experience with statistical data analysis and design of experiments\n\u2022 CAD design and drafting experience\n\u2022 Proven leader in a cross functional environment\n\u2022 Polished communicator\n\u2022 Excellent documentation writing skills; clear and concise using objective evidence and language\n\u2022 Excellent reputation for building relationships\n\u2022 Organized, on-time, and detailed project management skills\n\u2022 Energized attitude\n\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-08 18:57:29", "url": "http://jobs.sjm.com/xml/28541769/job", "country": "United States", "company": "St. Jude Medical", "title": "Engineer - Research & Development", "reqid": "13134", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 28541769}, {"country_short": "USA", "city": "Plymouth", "description": "Technician - Desktop Support\nJob Requisition #: 13135\nDate Posted: 05/08/2012\nCategory: Information Technology\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nPosition Summary:\nThe Desktop Support Technician I role operates as a first level of IT support within the Cardiovascular IT organization. This position focuses primarily on the level 1 support aspects of PC hardware, software and end user issues. This role will regularly interacts with both technical and business individuals, and has frequent direct contact with all levels of business users, ranging from manufacturing employees to executives. A professional appearance, service oriented demeanor, and good customer service skills are required. Overall work direction is given from the desktop support supervisor as well as the IT manager, however day to day guidance is also provided by the level II and senior desktop positions. The ability to escalate more involved technical issues to higher level technicians is important.\n\nEssential Functions:\n\u2022 Physical installation of PC's and related peripherals.\n\u2022 Perform warranty replacement on PC hardware.\n\u2022 Work with client images for deployment of operating systems to desktops.\n\u2022 Participate in deployment and support of applications, software, end user hardware in accordance with technology standards.\n\u2022 Provide level 1 support of both hardware and software issues.\n\u2022 Manage service requests using the incident management application.\n\u2022 Maintain documentation on procedures as required.\n\u2022 Support LAN connectivity from the workstation to the network switch for all client end points.\n\nOther Duties:\n\u2022 Participate as a project resource as necessary.\n\u2022 Assist in testing of updates within defined change control processes.\n\u2022 Effectively prioritize and execute tasks as directed by the desktop support supervisor.\n\u2022 Participate in cross divisional IT efforts as deemed necessary.\n\nQualifications:\n\u2022 1-3 years related IT support experience, or 2 - 4 year degree in related IT field desired.\n\u2022 Microsoft Certified Technical Specialist (MCTS) or IT Professional (MCTIP) in Microsoft Windows Operating System or Microsoft Office technologies a plus.\n\u2022 Experience in supporting manufacturing and clean room environments also plus.\n\u2022 Solid technical aptitude and troubleshooting skills.\n\u2022 Solid understanding of standard PC and related hardware.\n\u2022 Excellent communication and customer service skills.\n\u2022 Ability to communicate with both technical and non-technical individuals.\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-08 18:57:29", "url": "http://jobs.sjm.com/xml/28541771/job", "country": "United States", "company": "St. Jude Medical", "title": "Technician - Desktop Support", "reqid": "13135", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 28541771}, {"country_short": "USA", "city": "Plymouth", "description": "Group Lead - Production\nJob Requisition #: 13138\nDate Posted: 05/07/2012\nCategory: Production\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nFirst shift position: (5AM - 2:30PM; M-F)\n\nPosition Summary:\nEnsures the effective use of material, equipment and personnel in producing quality production; Responsible for ensuring inventory accuracy, cycle counts, and meeting build schedules;\n\nEssential Functions:\n\u2022 Manages directly the manufacture of medical device;\n\u2022 Ensures that quality and production goals are met;\n\u2022 Trains production operators on GMP, MP and retrain as needed;\n\u2022 Daily meeting with manufacturing operators for better communication and continuous improvement;\n\u2022 Organizes work schedule, Monitors performance and reports status;\n\u2022 Ensures PM (preventive maintenance) and Calibration stickers are up to date;\n\u2022 5S audit and weekly meeting with other area value stream group-leads in a organization; and more;\n\nQualifications:\n\u2022 Prefer two years of college or equivalent.\n\u2022 Prefer three - five years experience as a group-lead in a manufacturing environment.\n\u2022 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;\n\u2022 Computer skills desired in excel Microsoft word and have trained SAP (S2S) software\n\u2022 Ability to effectively work and communicate with others is critical.\n\u2022 Prefer pervious training experience in a manufacturing environment.\n\u2022 Six Sigma Green Belt Training\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-07 18:23:12", "url": "http://jobs.sjm.com/xml/28478543/job", "country": "United States", "company": "St. Jude Medical", "title": "Group Lead - Production", "reqid": "13138", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 28478543}, {"country_short": "USA", "city": "Plymouth", "description": "Senior Clinical Research Coordinator\nJob Requisition #: 13159\nDate Posted: 05/04/2012\nCategory: Clinical\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nThe Senior Clinical Research Coordinator will implement and carry out functions of clinical research.\n\nResponsibilities:\n\u2022 Follow department Standard Operating Procedures\n\u2022 Assist with pre study evaluations\n\u2022 Initiate clinical investigations by arranging proctoring and staff training\n\u2022 In-house case report form auditing and data verification\n\u2022 Assist with regulatory reports (annual reports, progress reports)\n\u2022 Work independently on specific study projects\n\u2022 Assist CRA in setting up sites (IRB approvals, Investigator agreements, and study start up)\n\u2022 Assist with monitoring visits\n\u2022 Interact with study sites\n- Generate follow up reminder reports and send to investigators on a regular basis\n\u2022 Acquire professional, product and market expertise via independent reading, networking and training\n\u2022 Resource/train other clinical research coordinators\n\u2022 Travel approximately 10%\n\u2022 Participate in professional activities outside of normal business hours\n\u2022 Other duties as requested\n\nRequirements:\nOne of the following:\n\u2022 High School Diploma with 4 years experience in an administrative role OR\n\u2022 BA/BS in Medical Science or Nursing or equivalent\n\u2022 3 years experience in clinical research, preferably medical device company\n\u2022 Computer proficiency required: Word, Excel, Access, PowerPoint, internet, email\n\u2022 Ability to constructively interact with a range of personalities and positions inside and outside the organization\n\u2022 Attention to detail\n\u2022 Ability to organize, prioritize, and manage tasks in a changing environment\n\u2022 Ability to work independently and take direction from others\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-04 19:20:11", "url": "http://jobs.sjm.com/xml/28440690/job", "country": "United States", "company": "St. Jude Medical", "title": "Senior Clinical Research Coordinator", "reqid": "13159", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 28440690}, {"country_short": "USA", "city": "Plymouth", "description": "Senior IT Business Analyst\nJob Requisition #: 13033\nDate Posted: 04/23/2012\nCategory: Information Technology\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nPosition Summary: Provides leadership and direction to and works with business customers in identifying and fulfilling their informational needs. Functions as a project leader for system analysis, design, development and implementation assignments.\n\nEssential Functions:\nProvides application development support and coordination primarily to the Clinical organization by:\n\u2022 Facilitating meetings in the business area to review business processes and identify information system requirements and/or needs.\n\u2022 Making appropriate recommendations for continuing, modifying, or abandoning proposed projects and/or systems based on the results of feasibility studies and/or cost/benefit analyses.\n\u2022 Maintaining and documenting the logical and physical data models including data flow diagrams.\n\u2022 Developing business process flows and data models required by the department methodology for new system development or for process redesign.\n\u2022 Preparing project and system documentation consistent with standards and procedures outlined in the development methodologies.\n\nProvides project management support as a leader or member of a project team:\n\u2022 Develops project plans, work breakdown structures and task dependencies, communication plans, etc., according to the development methodologies.\n\u2022 Manages project activities and motivates members of the project team.\n\u2022 Provides updates and thorough communication to the project team, information systems and the impacted business areas.\n\u2022 Coordinates the implementation of information systems with IS personnel and members of the impacted business areas.\n\nProvides coaching and training support:\n\u2022 Maintains proficiency in the tool sets used within the supported business areas.\n\u2022 Supports the business areas in their tool sets, including training and developing subject matter experts within the supported business areas.\n\u2022 Conducts training that quickly prepares participants to use a maximum of system features.\n\nMaintains relationships and communications with business and IS units:\n\u2022 Keeps informed of trends and new developments in technology to better advise management of means to accomplish business and information systems goals.\n\u2022 Understands the various business entities, their information systems developed by IS, and the applications that they developed on their own.\n\u2022 Serves as a liaison between IS and the supported business areas.\n\u2022 Communicates effectively with management to enhance their understanding of the opportunities and limitations of information systems.\n\u2022 Provides effective written and verbal communications.\n\nQualifications:\n\u2022 This person must have excellent communication and customer service skills and strong leadership and team motivation skills in order to manage work that requires effective delivery to internal SJM customers.\n\u2022 This includes bridging communication between technical areas and business areas for a full and complete understanding of expectations.\n\u2022 Five to seven years business analyst experience or equivalent gained through a combination of formal training and progressive work experience, including project management experience in Clinical or a related function.\n\u2022 Bachelor's degree in Business, Computer Science or related field is preferred.\n\u2022 MBA a plus.\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-23 20:17:20", "url": "http://jobs.sjm.com/xml/28080404/job", "country": "United States", "company": "St. Jude Medical", "title": "Senior IT Business Analyst", "reqid": "13033", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 28080404}, {"country_short": "USA", "city": "Plymouth", "description": "Clinical Research Associate\nJob Requisition #: 12963\nDate Posted: 04/20/2012\nCategory: Clinical\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nThe Clinical Research Associate will manage and execute assigned clinical studies with guidance. This will include Support professionalism and scientific expertise of department.\n\nResponsibilities:\nManages assigned clinical study centers\nSets up sites: clinical research agreements, site budgets, IRB Approvals, etc\nPrepares and maintains case report forms, informed consent and other specialized documents for clinical investigations\nConduct study training or other formal training at site and at the study team level\nAssists Regulatory in annual report and progress reports to the FDA\nReviews data forms and DCF generation\nResponsible for data review and approval of DCFs\nGenerates presentations when requested by investigators\nAcquires professional, product and market expertise via independent reading, networking and training\nTravels approximately 30% but varies according to trial needs\nParticipates in professional activities outside of normal business hours\nPerforms other related duties as requested\n\nRequirements:\nBA/BS in business, science or nursing\n3-5 years experience in clinical research including monitoring\nAbility to constructively interact with a range of personalities and range of positions, both inside and outside the organization\nExcellent written and verbal communication skills\nAbility to work independently and take direction from others\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-20 18:10:04", "url": "http://jobs.sjm.com/xml/28034728/job", "country": "United States", "company": "St. Jude Medical", "title": "Clinical Research Associate", "reqid": "12963", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 28034728}, {"country_short": "USA", "city": "Plymouth", "description": "Associate - Clinical Research\nJob Requisition #: 12962\nDate Posted: 04/20/2012\nCategory: Clinical\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nThe Clinical Research Associate II position will assist in the planning, designing, and execution of clinical studies under the supervision of the Clinical Manager with focus on compliance to applicable regulatory standards and monitoring of investigational centers.\n\nResponsibilities:\n\u2022 Assist with the management and development of study related documents including clinical protocols, case report forms, study manuals, and other study related tools.\n\u2022 Initiate site activation documentation\n\u2022 Participate in site qualification and site initiation process, including scheduling of monitor activities with site personnel.\n\u2022 Assist in planning and preparing materials for investigator and coordinator meetings.\n\u2022 Assist in training of investigators and coordinators.\n\u2022 Track and report progress of studies, e.g. subject screening and enrollment, data collection, documentation of adverse events.\n\u2022 Coordinate and conduct monitoring visits at participating centers to ensure compliance to the clinical protocol, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports\n\u2022 Assist in query generation and resolution.\n\u2022 Assist with core lab data management.\n\u2022 Assist with the development and implementation of site corrective actions as needed to address any noncompliance issues.\n\u2022 Write and/or provides input to the monitoring plan\n\u2022 Provide updates on progress of assigned clinical sites to study management.\n\u2022 Develop expertise with SOP's, GCP's, and regulatory compliance guidelines.\n\u2022 Participate in training/orientation or new employees.\n\u2022 Contribute to ongoing SOP review and development.\n\u2022 Review site changes to informed consent forms.\n\u2022 May create and conduct presentations.\n\nQualifications:\n\u2022 Four year degree in physical science\n\u2022 1-2 years experience monitoring\n\u2022 Experience directly supporting clinical research or similar experience in a medical/scientific area\n\u2022 Knowledge of clinical and outcomes research study design\n\u2022 Working knowledge of GCPs, and regulatory compliance guidelines for clinical trials\n\u2022 Knowledge of medical terminology\n\u2022 Able to travel 40% on average\n\u2022 High attention to detail and accuracy\n\u2022 Strong written and oral communications skills\n\u2022 Able to manage multiple tasks\n\u2022 Good problem-solving skills\n\u2022 Proficient computer skills (MS Office)\n\u2022 Current driver's license\n\nPreferred Qualifications:\n\u2022 Two years applicable health care experience\n\u2022 Advanced degree\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-20 18:09:59", "url": "http://jobs.sjm.com/xml/28034726/job", "country": "United States", "company": "St. Jude Medical", "title": "Associate - Clinical Research", "reqid": "12962", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 28034726}, {"country_short": "USA", "city": "Plymouth", "description": "Senior Clinical Safety Specialist\nJob Requisition #: 12987\nDate Posted: 04/20/2012\nCategory: Clinical\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nThe Senior Clinical Safety Specialist will work under the direction of the Senior Director, Medical/Scientific Affairs processing adverse events as defined per clinical protocols. This role will also assist with the education of clinical teams on identification and reporting of adverse events specific to clinical research projects.\n\nResponsibilities:\n\u2022 Process all adverse events per Work Instruction/ Protocol, working collaboratively with study specific CRAs to ensure comprehensive information is available for full review and reporting\n\u2022 Collaborate with Safety team members in preparation for DMC/DSMB/CEC meetings\n\u2022 Oversee weekly review of adverse events with applicable study teams\n\u2022 Review all adverse events in accordance with the specified Clinical Investigation Plan (CIP)\n\u2022 Code adverse events where directed by the governing processes\n\u2022 Draft AE narratives, as required, for inclusion in all FDA report submissions\n\u2022 Work with clinical study teams to ensure adherence to protocol, regulations and SJM policies regarding the reporting of adverse events\n\u2022 Maintain knowledge of current FDA, ICH, and ISO regulatory rules and policies affecting CVD Clinical study related products\n\u2022 Assist with training on study specific adverse event definitions prior to start of clinical study/registry and ongoing as needed to insure compliance and accurate reporting\n\u2022 Assist with revision or writing of SOP/Instructions/Procedures and changes to support clinical department\n\u2022 Assist in development of study specific case report forms\n\u2022 Assist in clinical study protocol development\n\u2022 Assist with BIMO audits, when directed\n\u2022 Collaborate on additional Clinical Research activities, as needed\n\u2022 Other duties as assigned\n\nRequirements:\n\u2022 Bachelor\u2019s degree in an area of science or RN\n\u2022 Strong understanding of adverse events and risk assessment\nOne of the following:\n\u2022 2-5 years experience within pharmacovigilance or medical safety\n\u2022 5+ years experience in medical device or Pharma in\nclinical research or risk assessment\n\n\u2022 Working knowledge of medical terminology, clinical research conduct, laws, regulations, and standards\n\u2022 Proficient in MS Office and database navigation skills\n\u2022 Strong interpersonal and communication skills\n\u2022 Excellent record keeping, organizational skills, and problem solving abilities\n\u2022 Highly motivated and capable of working independently and as a team member\n\u2022 Experience coordinating, prioritizing, and setting timelines for multiple tasks\n\u2022 Ability to multi-task and adapt to a rapid pace environment\n\u2022 Strong technical writing skills\n\nPreferred qualifications:\n\u2022 3-5 years of experience in a hospital or clinic setting, preferably within the cardiovascular arena\n\u2022 PharmD or PhD\n\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-20 18:09:08", "url": "http://jobs.sjm.com/xml/28034690/job", "country": "United States", "company": "St. Jude Medical", "title": "Senior Clinical Safety Specialist", "reqid": "12987", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 28034690}, {"country_short": "USA", "city": "Plymouth", "description": "Clinical Program Budget Manager\nJob Requisition #: 12522\nDate Posted: 04/12/2012\nCategory: Finance\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nThe Clinical Program Budget Analyst will develop, analyze, and facilitate the execution of all Cardiovascular Clinical Affairs study budgets. This position will work with all clinical program managers and directors to ensure clinical trial financial forecasts are updated accurately and efficiently and are consistent with organizational objectives.\n\nRESPONSIBILITIES\n\u2022 Assists the Clinical Program Budget Manager in communicating budget timelines and preparing budgets for review\n\u2022 Negotiates changes to Clinical Trial site reimbursements and new site reimbursement agreements\n\u2022 Identifies and resolves budget and negotiation issues to a satisfactory conclusion meeting the needs of both clinical site customer and core business\n\u2022 Assists on monthly and quarterly direct clinical trial expense reporting, accruals and forecasting\n\u2022 Compiles negotiated cost history comparing the average, median, high, and lowest costs negotiated for each clinical trial\n\u2022 Inputs budget data into the company's budget templates and software system\n\u2022 Provides analysis to Clinical Program Budget Manager on each clinical trial budget and edits to budgets\n\u2022 Reviews budget data on a monthly and quarterly basis with clinical trial program managers\n\u2022 Assists Clinical management on budget planning related to Strategic planning\n\u2022 Works closely with the Finance department to ensure transparency and continuity of AOP budget data and monthly expense analysis\n\u2022 Follows Clinical operational processes in the preparation of clinical trial budgets\n\u2022 Ensures accuracy and completeness of the negotiated site reimbursements for the planning and tracking system\n\u2022 Tracks the negotiated budgets against the AOP plan\n\nREQUIREMENTS:\n\u2022 Bachelor\u2019s degree in Finance or area of business management\n\u2022 2-4 years experience in finance and contract negotiation\n\u2022 Experience negotiating corporate or customer contracts\n\u2022 Knowledge of financial tracking software\n\u2022 Highly proficient in MS Excel\n\u2022 Experience structuring and performing sophisticated financial projections and analyses\n\u2022 Experience managing time efficiently and handling multiple tasks\n\u2022 Ability to assimilate detailed information into the bigger picture\n\u2022 Excellent written and oral communication skills with small or large group audiences\n\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-12 20:21:17", "url": "http://jobs.sjm.com/xml/27852714/job", "country": "United States", "company": "St. Jude Medical", "title": "Clinical Program Budget Manager", "reqid": "12522", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 27852714}, {"country_short": "USA", "city": "Plymouth", "description": "Medical and Scientific Affairs Director\nJob Requisition #: 12819\nDate Posted: 04/02/2012\nCategory: Clinical\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nSt. Jude Medical, Inc.\nJob Title: Director, Medical and Scientific Affairs\n\nDuties:\nPlan, direct, and coordinate medical and scientific activities related to clinical investigation and research.\nDetermine scientific goals, and develop and implement policies and procedures for clinical scientific research to ensure regulatory and industry requirements.\nOversee a research team engaged in a regulated industry clinical investigation and research, and serve as primary internal resource for medical and scientific guidance across current and future product lines.\nApplying highly developed management and leadership skills, manage medical and scientific team with primary purpose to provide in-depth medical and scientific support to company\u2019s cross functional development and execution team; serve as medical resource to create and implement clinical trial strategies and methodologies to obtain market approval; develop and maintain standards of care relevant to industry products and patient population and disease pathologies of interest.\nDevelop, implement, and oversee internal medical monitoring processes to include\nadverse event reporting and safety surveillance procedures.\nProvide oversight of independent committees including clinical events committees,\nand data safety monitoring procedures to ensure compliance with regulatory\nstandards and FDS expectations; assist Business Development in strategic\nplanning and due diligence activities; assist with development of educational\nmaterials, educational programs and participate in such.\n\nJob Requirements:\nM.D., or equivalent foreign degree as determined by a written evaluation, with at least six (6) years experience as clinical research scientist working with medical devices related to cardiology and cardiac procedures, including cardiac catherization, percutaneous coronary interventions, and cardiovascular/metabolism therapeutics.\nExperience must include designing and conducting multiple randomized, controlled clinical research trials using IND, NDA, IDE, and PMA submissions, and must include pharmamacovigilance with medical safety assessments, medical safety reports, and biocompatibility testing in compliance with CCP, ICH, and US FDA regulations.\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-03 03:22:11", "url": "http://jobs.sjm.com/xml/27603030/job", "country": "United States", "company": "St. Jude Medical", "title": "Medical and Scientific Affairs Director", "reqid": "12819", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 27603030}, {"country_short": "USA", "city": "Plymouth", "description": "Specialist - Regulatory Affairs\nJob Requisition #: 12900\nDate Posted: 04/02/2012\nCategory: Regulatory Affairs\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nThe Regulatory Affairs Specialist ensures products and procedures comply with regulatory agencies specifications.\n\nResponsibilities:\n\u2022 Prepare 510(k) regulatory applications and 510(k) letters to file to secure/maintain marketing approvals\n\u2022 Prepare new product Design Dossiers for submission to Notified Bodies and Health Canada\n\u2022 Prepare appropriate documentation for renewing CE mark certification\n\u2022 Prepare appropriate documentation for annual renewals submitted to Health Canada\n\u2022 Prepare Technical Files for product s with self certified CE Marks\n\u2022 Update Technical Files on annual basis\n\u2022 Review device labeling and advertising materials for compliance with FDA submissions and applicable regulations\n\u2022 Act as a core member on development teams, providing RA guidance, and project regulatory assessments\n\u2022 Work with Engineering teams (R&D, Quality, Design Assurance) to evaluate testing strategies\n\u2022 Interface directly with FDA, Notified Bodies and Health Canada\n\u2022 Communicate and coordinate regulatory activities with other departments\n\u2022 Review of product and manufacturing changes for compliance with applicable regulations\n\u2022 Review of protocols and reports to support regulatory submissions\n\u2022 Support international regulatory submissions (Korea, others)\n\u2022 Product support for minimally invasive structural heart technologies\n\u2022 Assist with IDE & PMA applications, amendments and supplements\n\nQualifications:\n\u2022 BA or BS in a technical discipline with at least four years technical experience\n\u2022 One to three years regulatory experience\n\u2022 Experience with 510(k) applications and US device regulations\n\u2022 Experience with EU and Canadian medical device regulations and submissions\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-03 03:21:52", "url": "http://jobs.sjm.com/xml/27603020/job", "country": "United States", "company": "St. Jude Medical", "title": "Specialist - Regulatory Affairs", "reqid": "12900", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 27603020}, {"country_short": "USA", "city": "Plymouth", "description": "Demand Planner\nJob Requisition #: 12663\nDate Posted: 03/21/2012\nCategory: Purchasing\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nPosition Summary:\nResponsible 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\n\nEssential Functions:\n\u2022 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\n\u2022 Clearly communicate agreed upon production quantities and mix to Production and other Operations groups.\n\u2022 Zero back order goal - when back order exists full responsibility for back order management, status, prioritization, communication\n\u2022 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\n\u2022 Set and maintain appropriate inventory levels that meet service level objectives to customers balanced with divisional DIOH (Days Inventory On Hand) goals.\n\u2022 Plan new product introductions and phase outs to achieve planned launch dates with targeted inventory levels\n\u2022 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\n\u2022 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\n\nQualifications:\n\u2022 Bachelor Degree required\n\u2022 APICS or other Planning related certifications preferred.\n\u2022 Minimum 3 years experience in Planning function\n\u2022 Medical Device experience preferred.\n\u2022 Experience with SAP preferred.\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-03-22 01:48:21", "url": "http://jobs.sjm.com/xml/27314755/job", "country": "United States", "company": "St. Jude Medical", "title": "Demand Planner", "reqid": "12663", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 27314755}, {"country_short": "USA", "city": "Plymouth", "description": "Demand Planner\nJob Requisition #: 12664\nDate Posted: 03/21/2012\nCategory: Operations\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nPosition Summary:\nResponsible 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\n\nEssential Functions:\n\u2022 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\n\u2022 Clearly communicate agreed upon production quantities and mix to Production and other Operations groups. Seamless coordination with Supply Chain Supply Side Planning to meet overall planning objectives\n\u2022 Manage Zero back order goal \u2013 when back order exists full responsibility for back order management, status, prioritization, communication\n\u2022 Sales and net requirements forecasts review and attainment, holding key geographies accountable to their forecasts thru measurement and communication\n\u2022 Set and maintain appropriate inventory levels that meet service level objectives to customers balanced with divisional DIOH (Days Inventory On Hand) goals.\n\u2022 Plan new product introductions and phase outs to achieve planned launch dates with targeted inventory levels\n\u2022 Facilitate and coordinate key CVD quarterly/annual planning processes like Strat Plan, OP Plan, and quarterly production volume and inventory forecasting\n\u2022 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.\n\u2022 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\n\u2022 Proficient in Excel, PowerPoint and other Microsoft software\nQualifications:\n\u2022 Bachelor Degree required.\n\u2022 APICS or other Planning related certifications preferred.\n\u2022 Minimum 3 years experience in Planning function.\n\u2022 Medical Device experience preferred.\n\u2022 Experience with SAP preferred.\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-03-22 01:48:21", "url": "http://jobs.sjm.com/xml/27314756/job", "country": "United States", "company": "St. Jude Medical", "title": "Demand Planner", "reqid": "12664", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 27314756}, {"country_short": "USA", "city": "Plymouth", "description": "Senior Data Warehouse Architect\nJob Requisition #: 12605\nDate Posted: 03/14/2012\nCategory: Information Technology\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nThe Senior Data Warehouse Architect will perform necessary duties to design/model, maintain, and optimize multiple data marts and data warehouses within our database environments. The architect will also share responsibilities for Extraction, Transformation & Loading for the data warehouse.\n\nResponsibilities:\n\u2022 Analysis, design, development & support of the CVD data warehouse environment\n\u2022 Team member to support Informatica & Business Objects\n\u2022 Assist in ETL development efforts, making sure that the business rules are implemented correctly\n\u2022 Diagnose and propose solutions for database and report performance issues\n\u2022 Other areas of responsibility are Data Strategy, ETL Architecture, ETL development, reference data management and data quality improvement\n\nRequirements:\n\u2022 Bachelor\u2019s degree\n\u2022 8+ years of IT experience\n\u2022 5+ years as a Data Architect\n\u2022 3-5 years experience with SQL Server\n\u2022 Full life cycle experience implementing BI architecture and data warehousing solutions\n\u2022 Strong conceptual, logical and physical data modeling experience\n\u2022 Performed and led data migration efforts\n\u2022 Thorough understanding of BI / DW concepts\n\u2022 Hands on experience in writing, executing and debugging SQL\n\u2022 Experienced with ER Diagrams and data modeling tools such as ErWin\n\u2022 Experience with identifying reporting and information requirements\n\u2022 Excellent communication skills\n\u2022 Strong analytical, problem solving, and research skills\n\nPreferred Qualifications:\n\u2022 Medical Device industry exposure or experience\n\u2022 Working knowledge of Informatica\n\u2022 Working knowledge of Oracle\n\u2022 Bachelors degree in CS, Mathematics, MIS, Engineering, etc.\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-03-14 19:07:30", "url": "http://jobs.sjm.com/xml/27138028/job", "country": "United States", "company": "St. Jude Medical", "title": "Senior Data Warehouse Architect", "reqid": "12605", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 27138028}, {"country_short": "USA", "city": "Plymouth", "description": "Senior Clinical Auditor\nJob Requisition #: 12534\nDate Posted: 02/21/2012\nCategory: Compliance\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nThe Senior Clinical Auditor will be a member of the Clinical Quality Assurance department within the St. Jude Medical (SJM) CVD Clinical Affairs. The primary responsibility is to implement and maintain written clinical procedures and systems that include a global perspective of medical device clinical trials and quality systems.\n\nResponsibilities:\n\u2022 Perform clinical audits\n\u2022 Manage and archive projects and documents\n\u2022 Communicate with St. Jude Medical departments and operations\n\u2022 Ensure clinical investigations are designed, conducted and monitored to comply with applicable global requirements\n\u2022 Train and educate personnel with proper interpretations of regulations and clinical systesm\n\u2022 Represent St. Jude Medical during agency and/or government inspections for clinical research\n\n\nRequirements:\n\u2022 Bachelor's degree preferred; additional relevant work experience in lieu of degree is acceptable.\n\u2022 5 yrs experience in Clinical Compliance, Regulatory and/or Clinical Affairs departments in FDA regulated company\n\u2022 Ability to understand clinical trial activities or have experience conducting clinical trial activities\n\u2022 Strong understanding and knowledge of the global medical device regulations that interact with clinical trial activities\n\u2022 Excellent organizational, interpersonal, and communication (verbal/written) skills\n\u2022 Computer proficiency in Microsoft Office applications, to include spreadsheet/graphics programs\n\u2022 Extensive working knowledge of national and international practices, guidance, standards and regulations\n\u2022 Ability to constructively interact with a range of personalities and positions, both inside and outside the organization\n\u2022 Ability to travel up to 50%\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-02-21 21:41:32", "url": "http://jobs.sjm.com/xml/26658163/job", "country": "United States", "company": "St. Jude Medical", "title": "Senior Clinical Auditor", "reqid": "12534", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 26658163}, {"country_short": "USA", "city": "Plymouth", "description": "Clinical Programs Manager\nJob Requisition #: 12409\nDate Posted: 02/13/2012\nCategory: Clinical\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nThe Clinical Programs Manager will manage the successful completion of all clinical programs. Responsible for developing program budgets and hitting both enrollment and spending targets. Staff, manage and ensure competency of Clinical Research Associates including their knowledge and compliance with SOPs. Manage the timely development of PMA and other regulatory submissions.\n\nResponsibilities:\nManage the successful and timely execution of all device clinical trials\nResponsible for the selection, training and management of all Clinical Research Associates including their training and compliance with all SOPs and associated regulations\nResponsible for the training, initiation and management of clinical trial sites\nEstablish and manage trial budgets including enrollment targets\nReport regularly on performance against plan including steps to overcome any shortfalls in enrollment or overages in spending\nParticipate in the design and development of new trials\nResponsible for the timely development of clinical component of regulatory submissions including 510(k)s and PMAs including validation of the associated data analysis\nDevelop and maintain individual training programs for all staff\nAble to assist in the drafting and development of publications based on the results of the clinical trials\nDevelop and maintain strong relationships with principal investigators at clinical trial sites\nTravel estimated at15%\n\nRequirements:\nBA/BS in life sciences or nursing\n10+ years experience in clinical research\n5+ years experience successfully managing a team of clinical research professionals\n5+ years clinical research experience in medical device\nDemonstrated knowledge of and experience with GCP and all US regulations\nHands on experience in IDE clinical trials and the preparation of PMAs\nComfortable in both the clinical and business setting\nComfortable presenting to senior management\nAbility to work independently and take direction from others\nStrong work ethic\nExcellent communication, problem-solving and organizational skills\nComputer proficiency including Microsoft Office applications\n\nPreferred Qualifications:\nAdvanced degree in life sciences or nursing a strong plus\nExperience in the cardiovascular therapeutic areas\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-02-13 22:34:16", "url": "http://jobs.sjm.com/xml/26501390/job", "country": "United States", "company": "St. Jude Medical", "title": "Clinical Programs Manager", "reqid": "12409", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 26501390}, {"country_short": "USA", "city": "Plymouth", "description": "Clinical Programs Manager\nJob Requisition #: 12506\nDate Posted: 02/10/2012\nCategory: Clinical\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nThe Clinical Programs Manager will manage the successful completion of all clinical programs. Will also be responsible for developing program budgets and hitting both enrollment and spending targets. Staff, manage and ensure competency of Clinical Research Associates including their knowledge and compliance with SOPs. Manage the timely development of PMA and other regulatory submissions.\n\nResponsibilities:\n\u2022 Manage the successful and timely execution of all device clinical trials\n\u2022 Responsible for the selection, training and management of all Clinical Research Associates including their training and compliance with all SOPs and associated regulations\n\u2022 Responsible for the training, initiation and management of clinical trial sites\n\u2022 Establish and manage trial budgets including enrollment targets\n\u2022 Report regularly on performance against plan including steps to overcome any shortfalls in enrollment or overages in spending\n\u2022 Participate in the design and development of new trials\n\u2022 Responsible for the timely development of clinical component of regulatory submissions including 510(k)s and PMAs including validation of the associated data analysis\n\u2022 Develop and maintain individual training programs for all staff\n\u2022 Able to assist in the drafting and development of publications based on the results of the clinical trials\n\u2022 Develop and maintain strong relationships with principal investigators at clinical trial sites\n\u2022 Ensure that St. Jude Medical is using the most current tools in the management of clinical trials\n\u2022 Travel estimated at 30%\n\nRequirements:\n\u2022 BA/BS in life sciences or nursing\n\u2022 10+ years experience in clinical research\n\u2022 5+ years experience successfully managing a team of clinical research professionals\n\u2022 3-5 years clinical research experience in medical device PREFERABLY\n\u2022 Demonstrated knowledge of and experience with GCP and all US regulations\n\u2022 Hands on experience in IDE clinical trials and the preparation of PMAs\n\u2022 Comfortable in both the clinical and business setting\n\u2022 Comfortable presenting to senior management\n\u2022 Ability to work independently and take direction from others\n\u2022 Strong work ethic\n\u2022 Excellent communication, problem-solving and organizational skills\n\u2022 Computer proficiency including Microsoft Office applications\n\nPreferred Qualifications:\n\u2022 Advanced degree in life sciences or nursing a strong plus\n\u2022 Knowledge and experience with European and Japan device clinical trials a strong plus\n\u2022 Experience in the cardiovascular therapeutic areas\n\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-02-10 23:21:31", "url": "http://jobs.sjm.com/xml/26467931/job", "country": "United States", "company": "St. Jude Medical", "title": "Clinical Programs Manager", "reqid": "12506", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 26467931}, {"country_short": "USA", "city": "Plymouth", "description": "Clinical Research Associate II\nJob Requisition #: 12425\nDate Posted: 02/07/2012\nCategory: Clinical\nLocation: Plymouth - MN - USA\n\n\nAbout Us\nOur 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?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.\n\nJob Overview\nThe Clinical Research Associate II designs, implements, monitors and closes out clinical investigations. Support professionalism and scientific expertise of department.\n\nResponsibilities:\n\u2022 Follows department Standard Operating Procedures\n\u2022 Sets up sites: clinical research agreements, IRB Approvals, etc\n\u2022 Prepares and maintains in-service manuals, case report forms, informed consent and other specialized documents for clinical investigations\n\u2022 Assists Regulatory in annual report and progress reports to the FDA\n\u2022 Organizes Investigator and Data Safety Monitoring Board meetings\n\u2022 Reviews data forms and DCF generation\n\u2022 Conducts field audits to assure protocol compliance and data integrity\n\u2022 Generates presentations when requested by investigators of AGA personnel\n\u2022 Generates follow-up reminder reports and sends to investigators or AGA personnel\n\u2022 Assists Regulatory Affairs in preparation of safety, efficacy and performance inquiries\n\u2022 Acquires professional, product and market expertise via independent reading, networking and training\n\u2022 Counsels and trains newly hired CRAs and monitors\n\u2022 Travels approximately 20%\n\u2022 Participates in professional activities outside of normal business hours\n\u2022 Performs other related duties as requested\n\nRequirements:\n\u2022 BA/BS in business, science or nursing\n\u2022 2 - 4 years experience in clinical research including monitoring\n\u2022 Ability to constructively interact with a range of personalities and range of positions, both inside and outside the organization\n\u2022 Excellent written and verbal communication skills\n\u2022 Ability to work independently and take direction from others\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-02-08 07:39:11", "url": "http://jobs.sjm.com/xml/26394667/job", "country": "United States", "company": "St. Jude Medical", "title": "Clinical Research Associate II", "reqid": "12425", "state": "Minnesota", "state_short": "MN", "location": "Plymouth, MN", "uid": 26394667}]