Boston Scientific Gruppe
Sr R & D Engineer - Sustaining
Boston Scientific Gruppe, Minnetonka, Minnesota, United States, 55345
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.
About the role:
As a
Senior R&D Engineer , you will be a member of the Sustaining R&D team within Boston Scientific’s Urology Division. This division supports design and sustain technologies for treating a wide range of urology-based issues including implants for treatment of urinary incontinence and erectile dysfunction, in addition to supporting evolving regulatory and standard requirements around product design. In this role, you will lead cross-functional teams to develop/modify products, materials, processes, or equipment for projects of moderate and difficult complexity. Under limited supervision/guidance, you will compile, analyze, and report operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials. This position is currently based at our Minnetonka, MN site. Please note that the role may relocate to our Maple Grove, MN site in the future. Candidates must be willing and able to transition to the new location if required. Your responsibilities will include: Successfully lead project teams typically including the following activities: design development, design modification assessment, experiment design and execution, establishment of specifications and drawings, test of materials/products, research investigations, team report-outs, report preparation and test documentation, and cross-functional collaboration to drive all areas of project execution based on design controls knowledge and other impacted areas Provide design engineering support for assigned Sustaining projects Serve as a R&D lead within a project Work independently to plan and schedule own activities necessary to communicate and meet timelines Design and coordinate engineering tests, experiments, and test equipment for R&D purposes Perform troubleshooting and problem-solving on complex product/process issues related to design, materials or process Summarize, analyze and draw conclusions from test results Prepare standard reports/documentation to communicate results to technical community Effectively communicate and present project status and technical details to management Responsible for engineering documentation Train, provide work direction, and/or mentor lab technicians or junior engineers Work cross-functionally with manager, project management, quality, process development, manufacturing, regulatory, clinical and marketing personnel to ensure project success Demonstrate strong design control knowledge and the Product Life Cycle through generation of high-quality deliverables Required qualifications: Bachelor’s Degree in Engineering – Biomedical or Mechanical engineering preferred 5+ years of work experience in engineering 2+ years of experience on medical device product development or sustaining projects Experience with design change assessment or impact analysis for regulated products Demonstrated ability to lead cross-functional teams/projects and influence outcomes without formal authority Strong understanding of design controls and risk management within the medical device industry Fundamental understanding of the Quality System per ISO 13485 or 21 CFR 820 Preferred qualifications: Biomedical or anatomical understanding of urological systems Strong statistical understanding and data analysis experience Experience working with cross-cultural teams Experience with polymer-based medical devices (silicone-based preferred) Experience with product lifecycle management systems (e.g. Windchill) Technical Project Management experience Self-starter with the ability to work independently and with a team to plan, schedule and execute activities necessary to meet project timelines to schedule and within budget Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
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Senior R&D Engineer , you will be a member of the Sustaining R&D team within Boston Scientific’s Urology Division. This division supports design and sustain technologies for treating a wide range of urology-based issues including implants for treatment of urinary incontinence and erectile dysfunction, in addition to supporting evolving regulatory and standard requirements around product design. In this role, you will lead cross-functional teams to develop/modify products, materials, processes, or equipment for projects of moderate and difficult complexity. Under limited supervision/guidance, you will compile, analyze, and report operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials. This position is currently based at our Minnetonka, MN site. Please note that the role may relocate to our Maple Grove, MN site in the future. Candidates must be willing and able to transition to the new location if required. Your responsibilities will include: Successfully lead project teams typically including the following activities: design development, design modification assessment, experiment design and execution, establishment of specifications and drawings, test of materials/products, research investigations, team report-outs, report preparation and test documentation, and cross-functional collaboration to drive all areas of project execution based on design controls knowledge and other impacted areas Provide design engineering support for assigned Sustaining projects Serve as a R&D lead within a project Work independently to plan and schedule own activities necessary to communicate and meet timelines Design and coordinate engineering tests, experiments, and test equipment for R&D purposes Perform troubleshooting and problem-solving on complex product/process issues related to design, materials or process Summarize, analyze and draw conclusions from test results Prepare standard reports/documentation to communicate results to technical community Effectively communicate and present project status and technical details to management Responsible for engineering documentation Train, provide work direction, and/or mentor lab technicians or junior engineers Work cross-functionally with manager, project management, quality, process development, manufacturing, regulatory, clinical and marketing personnel to ensure project success Demonstrate strong design control knowledge and the Product Life Cycle through generation of high-quality deliverables Required qualifications: Bachelor’s Degree in Engineering – Biomedical or Mechanical engineering preferred 5+ years of work experience in engineering 2+ years of experience on medical device product development or sustaining projects Experience with design change assessment or impact analysis for regulated products Demonstrated ability to lead cross-functional teams/projects and influence outcomes without formal authority Strong understanding of design controls and risk management within the medical device industry Fundamental understanding of the Quality System per ISO 13485 or 21 CFR 820 Preferred qualifications: Biomedical or anatomical understanding of urological systems Strong statistical understanding and data analysis experience Experience working with cross-cultural teams Experience with polymer-based medical devices (silicone-based preferred) Experience with product lifecycle management systems (e.g. Windchill) Technical Project Management experience Self-starter with the ability to work independently and with a team to plan, schedule and execute activities necessary to meet project timelines to schedule and within budget Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
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