Boston Scientific Gruppe
Principal R&D Engineer
Boston Scientific Gruppe, Marlborough, Massachusetts, us, 01752
Innovation - Diversity - Caring - Global Collaboration - Winning Spirit - High Performance
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. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
Principal R&D Engineer – Urology Products
Marlborough, MA
Be a technical leader in the fast-paced world of Boston Scientific Urology acquisitions and integrations! The Principal R&D Engineer for business integration will lead a cross-discipline team of engineers to assess design effectiveness of medical devices as well as compliance with Boston Scientific requirements and international standards as part of an acquisition and integration of a third-party company. This role would be responsible for assessing the acquired company’s Design History File (DHF) and updating associated design documentation and design outputs to address any gaps against the Boston Scientific Quality Management System.
You will conduct development and/or design integration work as part of a major acquisition/integration project. The Principal R&D Engineer would be viewed as an expert in Product Design History File (DHF) integration and/or associated medical device technologies.
Your responsibilities include:
Identifying gaps in the acquired company’s compliance to Boston Scientific Work Instructions and SOPs and defining strategy to close these gaps.
Directing day-to-day work of less experienced engineers and technicians within core product integration team and delegating work appropriately to meet project goals.
Coordinating, managing, and documenting project goals and progress and recommending appropriate revisions.
Communicating progress, risks, and trade-offs of technical deliverables to project leadership, and recommending revisions as needed.
Driving complex or novel assignments requiring the development of new or improved techniques and procedures. Work is expected to result in efficient and effective integration of medical device technologies to the Boston Scientific portfolio.
Successfully completing engineering work in one or more of the following: technology development or remediation, product design refinement, test of materials, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
Providing guidance to product and technology teams.
Assessing the feasibility and soundness of alternative engineering processes, products, or equipment.
Developing and coaching others on engineering documentation.
Demonstrating Technology Development and Product Development system knowledge through coaching and delivery of high quality, high impact deliverables.
Required Minimum Qualifications:
Bachelor’s degree or above in Mechanical Engineering, Biomedical Engineering, or related field.
8+ years of Medical Device Engineering experience with Bachelor’s degree, or 6+ years with Master’s.
Ability to provide technical leadership as it relates to product design and prioritization and to delegate work appropriately.
Strong mechanical and/or systems engineering and problem-solving skills.
Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources.
Strong written and verbal communication, judgment, decision-making, and critical thinking skills.
Excellent organizational, communication, and collaboration skills.
15% travel.
Willing to work onsite 3+ days per week at our Marlborough, MA location.
Preferred Qualifications:
Understanding of IEC 60601 Medical Electrical Equipment standards, including laser-specific sections.
Experience in single-use device or medical electrical equipment.
Experience with System Design Verification testing and data analysis.
Experience with Minitab.
Ability to build strong relationships across the organization and with external stakeholders.
Experience in driving technical trade-off decisions to optimize design, performance, usability, manufacturability, cost-efficiency and reliability.
Requisition ID:
596708
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596708
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