Boston Scientific - Marlborough, MA

posted 23 days ago

Full-time - Mid Level
Hybrid - Marlborough, MA
Miscellaneous Manufacturing

About the position

The R&D Engineer III position at Boston Scientific focuses on supporting the integration of medical devices through the assessment of design effectiveness and compliance with company standards. This role involves evaluating the Design History File of acquired companies and updating design documentation to align with Boston Scientific's Quality Management System. The engineer will work closely with subject matter experts to provide design solutions and technical support, utilizing their expertise in mechanical and systems design, testing, and statistical analysis.

Responsibilities

  • Identifying gaps in the acquired company's compliance to Boston Scientific Work Instructions and SOPs and defining strategy to close these gaps.
  • Providing input to project goals and progress and recommending appropriate revisions.
  • Communicating progress, risks, and trade-offs of technical deliverables to project leadership, and recommends revisions as needed.
  • Completing complex or novel assignments requiring the development of new or improved techniques and procedures.
  • Successfully completing engineering work in technology development or remediation, product design refinement, test of materials, preparation of specifications, process study, and report preparation.
  • Assessing the feasibility and soundness of alternative engineering processes, products, or equipment.
  • Completing clear and concise engineering documentation.
  • Demonstrating Technology Development and Product Development system knowledge through delivery of high quality, high impact deliverables.

Requirements

  • BS or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
  • 4+ years of engineering experience with Bachelor's degree, or 2+ years with Master's
  • Strong mechanical and/or systems engineering and problem-solving skills and attention to detail
  • Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
  • Strong written and verbal communication, judgment, decision-making, collaboration, and critical thinking skills
  • Personal drive, individual accountability & a strong bias for action.

Nice-to-haves

  • Familiarity with IEC 60601 Medical Electrical Equipment standards, including laser-specific sections
  • Experience in Minitab
  • Experience in single-use device or medical electrical equipment System Design Verification testing and data analysis
  • Ability to build strong relationships across the organization and with external stakeholders.

Benefits

  • Access to the latest tools, information, and training to advance skills and career
  • Support in progressing career ambitions
  • Diverse and high-performing teams
  • Opportunities for professional development and learning
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