Staff Mechanical Engineer

SUMMARY OF ROLE:

The Staff Mechanical Engineer will be responsible for performing all engineering functions across all stages of the product development, including system architecting, requirements definition, concept generation, prototyping, design verification testing, and reporting. The Staff Mechanical Engineer will also support monitoring device performance in the field, troubleshooting, leading design improvements, and providing production support, including production at scale.

This position will initially be based in our San Francisco, CA office and is expected to transition to our Redwood City, CA location by the end of December 2026.

RESPONSIBILITIES:

• Leverages experience and mechanical engineering knowledge along with systems and medical device understanding to design and develop products / product features
• Lead product design throughout its lifecycle, driving changes from initial concept to final production utilizing GDP and releasing documentation through ECO process
• Generates and maintains relevant design documentation including DFMEA, risk analysis, requirements definition, engineering drawings, tolerance stack-up, computational analysis
• Works closely with cross-functional team members (including Electrical, Clinical, Quality, Regulatory, Systems, amongst others) in developing design solutions
• Interfaces with the vendors for fabrication and assembly activities to ensure parts conform to engineering specifications, design documentation & manufacturing requirements
• Develops test plans, test protocols, test reports, performs sub-assembly and system-level verification testing. Designs and documents fixtures for testing product / sub-assemblies
• Performs investigation sand root cause analyses for field or manufacturing failures
• Works closely with Systems Engineering and other functions to develop regression test plans for design changes
• Develops project plans and schedules and tracks deliverables progress
• Ability to understand latest applicable national and international standards ensuring the product design complies to them
• As a key member of a cross-functional team, ensure smooth transition of new products into manufacturing environment in low-cost global regions
• Perform any other duties assigned related to product development
• Interfaces with vendors and/or directs or coordinates prototype fabrication and assembly activities to ensure products and systems conform to engineering specifications; documents designs and manufacturing recommendations
• Approximately 10 – 15% travel required, including international

QUALIFICATIONS:

• MSME or BSME with at least 10+ years of experience in 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 system and medical product development processes including risk management
• Experience in Injection molding (IM) and interacting with IM vendors
• Experience with die-cutting and converting desirable
• Experience with mechanical designs which include electronics integration desirable
• Excellent written and verbal communication with all levels of technical and operations

BENEFITS:

Element Science offers a very competitive salary and benefits package including, but not limited to:

• Stock Options
• 90% employer-paid medical, dental, and vision insurance
• Company-paid Basic Life Insurance
• 401(k) retirement plan (Traditional and Roth)
• Competitive Paid Time Off
• Paid Holidays
• FSA (Flexible Spending Accounts)
• HSA (Health Savings Account)
• Employee Assistance Program through PEO

The salary for this exempt-level position will be based on experience and qualifications within an established pay range.

• Pay range: $150,000 - $177,000