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Senior R&D Engineer, Med Device

Senior R&D Engineer, Med Device

Eliassen GroupHayward, CA, US
14 hours ago
Job type
  • Full-time
Job description

Job Description

BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION

Our client is a privately held medical device company based in Northern California growing rapidly in the development of disease-modifying therapies that improve survival, quality of life, and outcomes for patients with bronchitis, cardiac conditions, lung cancer, COPD, asthma, and other pulmonary diseases. They are building a portfolio of technologies to address the needs of interventional pulmonologists and radiologists, cardiac and thoracic surgeons, and physicians who treat pulmonary disease.

They are seeking a Sr. R&D Engineer – Design Controls & Risk Management to support on-going development programs. This role is critical for ensuring robust design practices, regulatory compliance, and effective cross-functional collaboration throughout the product lifecycle. The position will focus on authoring / owning requirement documents, traceability matrix, and Risk Management documents, while also managing external vendor / supplier activities such as Transit / Environmental Testing, Sterilization, and Biocompatibility testing.

DUTIES / EXPECTATIONS OF THIS ROLE

  • Prepare and present structured technical documentation and summaries for internal and external stakeholders.
  • Lead the development, documentation, and maintenance of Design Control elements including User Needs, Design Inputs / Outputs, DV protocols, test cases, and reports.
  • Create and maintain Risk Management documentation in accordance with ISO 14971 (Design, Use-Related, Process, Software).
  • Manage and maintain the Input / Output Trace Matrix using JAMA Software, ensuring alignment between requirements, risks, and V&V activities.
  • Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, and Operations teams to ensure cohesive development and regulatory alignment.
  • Participate in and / or lead formal design reviews, risk reviews, and test planning sessions.
  • Provide input and oversight for Design Verification testing to ensure coverage of requirements and risk mitigations.
  • Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971.

MUST HAVES - QUALIFICATION SUMMARY

  • Bachelor’s or advanced degree in Mechanical or Biomedical Engineering (other engineering disciplines considered with medical device experience).
  • 5+ years of experience developing or supporting capital equipment and / or disposable medical devices (energy-based device space preferred).
  • Proven experience authoring and managing requirements, traceability matrix, and risk documentation.
  • Strong knowledge of Design Control and Risk Management requirements under FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971.
  • Proficiency in authoring risk assessment documents (e.g., FMEA) and understanding risk methodologies.
  • Strong attention to detail with a systematic approach to documentation and traceability.
  • Excellent organizational and communication skills with the ability to manage multiple priorities.
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