Medical Devices, Digital Health, Wearable Technology

Staff Mechanical Engineer

Redwood City, CAOnsiteFull TimeStaff$170,000–$205,000 /yrPosted 2 months ago

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Required skills

MSME
BSME
Solidworks
PDM
DFMEA
risk management
Injection molding
die-cutting
converting
electronics integration

Role summary

The Staff Mechanical Engineer will lead product design across the entire lifecycle, from concept to production, in the medical device industry. Responsibilities include system architecting, requirements definition, prototyping, design verification testing, field performance monitoring, troubleshooting, and production support. The role requires expert proficiency in CAD (Solidworks preferred), mechanical drafting, PDM, quality systems, medical product development processes, and risk management. Experience with injection molding is essential, with die-cutting and electronics integration being desirable. This position is initially based in San Francisco, CA, transitioning to Redwood City, CA.

Element Science, Inc. is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home. Our mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions at the intersection of clinical-grade wearables, advanced algorithms, and therapy delivery.

We are entering an exciting phase of growth as we move from development into early commercialization. Our approach combines hardware, software, and services to deliver a more personalized and seamless patient experience—designed with both patients and clinicians in mind. Our product, a wearable patch defibrillator, is designed for patients with a temporary elevated risk of sudden cardiac arrest, addressing a significant and underserved population of over 500,000 patients in the U.S. By focusing on comfort, usability, and clinical effectiveness, we aim to transform the standard of care during this critical period. Headquartered in the San Francisco Bay Area, Element Science is backed by leading healthcare and technology investors, including Third Rock Ventures, GV (Google Ventures), Deerfield Healthcare, Cormorant Asset Management, and Invus Opportunities.

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: $170,000 - $205,000

Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job.

At this time, we are unable to offer relocation assistance at Element Science.

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Staff Mechanical Engineer

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