Senior R&D Engineer, Med Device

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