Boston Scientific
Sr R & D Engineer - Sustaining
Boston Scientific, Minnetonka, Minnesota, United States, 55345
Overview
Additional Location(s): US-MN-Maple Grove. Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance Boston Scientific offers opportunities to work with diverse, high-performing teams on important health industry challenges. You’ll have access to the latest tools, information and training to advance your skills and career, with support for your ambitions. 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 urinary incontinence and erectile dysfunction, and supports evolving regulatory and standard requirements around product design. You will lead cross-functional teams to develop/modify products, materials, processes or equipment for projects of moderate to difficult complexity. Under limited supervision, you will compile, analyze and report operational, test and research data to establish performance standards for newly designed or modified products, processes and materials. You will perform design change analyses to determine impact to the design history file and ensure deliverables needed to support design changes are executed to achieve project goals. A successful candidate will excel in a collaborative environment, possess strong technical skills in design elements and interactions, and demonstrate a proven ability to influence projects. This position is based at Minnetonka, MN with potential relocation to Maple Grove, MN in the future. Candidates must be willing and able to transition to the new location if required. Relocation assistance is not available at this time. Boston Scientific will not offer sponsorship or assume sponsorship for employment visas for this position at this time. Your responsibilities will include
Lead project teams including design development, design modification assessment, experiment design and execution, establishment of specifications and drawings, testing of materials/products, research investigations, reporting, and cross-functional collaboration to drive project execution based on design controls knowledge. Provide design engineering support for assigned Sustaining projects. Serve as an R&D lead within a project. Plan and schedule activities to communicate and meet timelines independently. Design and coordinate engineering tests, experiments, and test equipment for R&D purposes. Troubleshoot and solve 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 the technical community. Present project status and technical details to management. Maintain engineering documentation; train, provide work direction and mentor lab technicians or junior engineers. Collaborate with management, project management, quality, process development, manufacturing, regulatory, clinical and marketing to ensure project success. Demonstrate strong design control knowledge and the Product Life Cycle through high-quality deliverables. Required qualifications
Bachelor\'s Degree in Engineering - Biomedical or Mechanical engineering preferred 5+ years of engineering experience 2+ years of medical device product development or sustaining project experience Experience with design change assessment or impact analysis for regulated products Ability to lead cross-functional teams/projects and influence outcomes without formal authority Strong understanding of design controls and risk management in medical devices Fundamental understanding of ISO 13485 or 21 CFR 820 Quality System 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 plan, schedule and execute activities to meet project timelines and budgets Requisition ID:
613580 Salary range:
Minimum $82,600 - Maximum $156,900 The anticipated compensation and benefits vary by location and other factors. Compensation is commensurate with experience, education and qualifications. It is not typical to be hired at the bottom or top of the posted range. Compensation for non-exempt (hourly), non-sales roles may include variable compensation and annual bonus targets. Exempt, non-sales roles may include variable compensation, such as annual bonuses and long-term incentives. For MA positions: It is unlawful to require or administerlie detector tests for employment. Violators are subject to penalties. Equal opportunity and policies
Boston Scientific is an equal opportunity employer. We are committed to inclusion, equality and opportunity for all, recognizing the value of diverse backgrounds and perspectives. We comply with all applicable laws and healthcare credentialing requirements, including COVID-19 vaccination policies where required. The role may be safety-sensitive and subject to prohibited substance testing in accordance with applicable laws.
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Additional Location(s): US-MN-Maple Grove. Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance Boston Scientific offers opportunities to work with diverse, high-performing teams on important health industry challenges. You’ll have access to the latest tools, information and training to advance your skills and career, with support for your ambitions. 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 urinary incontinence and erectile dysfunction, and supports evolving regulatory and standard requirements around product design. You will lead cross-functional teams to develop/modify products, materials, processes or equipment for projects of moderate to difficult complexity. Under limited supervision, you will compile, analyze and report operational, test and research data to establish performance standards for newly designed or modified products, processes and materials. You will perform design change analyses to determine impact to the design history file and ensure deliverables needed to support design changes are executed to achieve project goals. A successful candidate will excel in a collaborative environment, possess strong technical skills in design elements and interactions, and demonstrate a proven ability to influence projects. This position is based at Minnetonka, MN with potential relocation to Maple Grove, MN in the future. Candidates must be willing and able to transition to the new location if required. Relocation assistance is not available at this time. Boston Scientific will not offer sponsorship or assume sponsorship for employment visas for this position at this time. Your responsibilities will include
Lead project teams including design development, design modification assessment, experiment design and execution, establishment of specifications and drawings, testing of materials/products, research investigations, reporting, and cross-functional collaboration to drive project execution based on design controls knowledge. Provide design engineering support for assigned Sustaining projects. Serve as an R&D lead within a project. Plan and schedule activities to communicate and meet timelines independently. Design and coordinate engineering tests, experiments, and test equipment for R&D purposes. Troubleshoot and solve 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 the technical community. Present project status and technical details to management. Maintain engineering documentation; train, provide work direction and mentor lab technicians or junior engineers. Collaborate with management, project management, quality, process development, manufacturing, regulatory, clinical and marketing to ensure project success. Demonstrate strong design control knowledge and the Product Life Cycle through high-quality deliverables. Required qualifications
Bachelor\'s Degree in Engineering - Biomedical or Mechanical engineering preferred 5+ years of engineering experience 2+ years of medical device product development or sustaining project experience Experience with design change assessment or impact analysis for regulated products Ability to lead cross-functional teams/projects and influence outcomes without formal authority Strong understanding of design controls and risk management in medical devices Fundamental understanding of ISO 13485 or 21 CFR 820 Quality System 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 plan, schedule and execute activities to meet project timelines and budgets Requisition ID:
613580 Salary range:
Minimum $82,600 - Maximum $156,900 The anticipated compensation and benefits vary by location and other factors. Compensation is commensurate with experience, education and qualifications. It is not typical to be hired at the bottom or top of the posted range. Compensation for non-exempt (hourly), non-sales roles may include variable compensation and annual bonus targets. Exempt, non-sales roles may include variable compensation, such as annual bonuses and long-term incentives. For MA positions: It is unlawful to require or administerlie detector tests for employment. Violators are subject to penalties. Equal opportunity and policies
Boston Scientific is an equal opportunity employer. We are committed to inclusion, equality and opportunity for all, recognizing the value of diverse backgrounds and perspectives. We comply with all applicable laws and healthcare credentialing requirements, including COVID-19 vaccination policies where required. The role may be safety-sensitive and subject to prohibited substance testing in accordance with applicable laws.
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