Our client is a medical device company moving from development into early commercialization, developing Class III products that combine hardware, software, and services around the patient experience.

They are seeking a Staff Mechanical Engineer to perform engineering functions across every stage of product development — system architecting, requirements definition, concept generation, prototyping, design verification testing, and reporting — and to support products in the field, lead design improvements, and provide production support, including production at scale.

This is a full-time hybrid role requiring at least 2 days/week onsite, based in the client's SF Peninsula, CA area office, with approximately 10–15% travel, including international.

Key Responsibilities

• Apply mechanical engineering knowledge, along with systems and medical device understanding, to design and develop products and product features.
• Lead product design through its lifecycle, driving changes from initial concept to final production using good documentation practices and releasing documentation through the ECO process.
• Generate and maintain design documentation, including DFMEA, risk analysis, requirements definition, engineering drawings, tolerance stack-ups, and computational analysis.
• Work closely with cross-functional team members, including Electrical, Clinical, Quality, Regulatory, and Systems, to develop design solutions.
• Interface with vendors on fabrication and assembly, and coordinate prototype builds, to ensure parts conform to engineering specifications, design documentation, and manufacturing requirements.
• Develop test plans, protocols, and reports; perform sub-assembly and system-level verification testing; and design and document test fixtures.
• Perform failure analysis and root cause investigations for field and manufacturing failures.
• Work with Systems Engineering and other functions to develop regression test plans for design changes.
• Develop project plans and schedules, and track deliverables.
• Stay current on applicable national and international standards and ensure product designs comply.
• Help ensure smooth transition of new products into manufacturing in low-cost global regions.

Requirements

• MSME or BSME with 10+ years of experience designing, prototyping, and testing in the medical device industry.
• Expert proficiency with CAD (SolidWorks preferred), mechanical drafting standards, and versioning (PDM).
• In-depth experience with quality systems and medical product development processes, including risk management.
• Experience with injection molding and working with injection molding vendors.