VP, Medical Device Engineering
- Location
- Menlo Park, CA · On-site
- Job type
- Full-time
- Level
- Executive
- Experience
- 15+ years
- Education
- Bachelor's degree
- Listed
- 14 days ago
Skills & highlights for this role
- Medical device industry experience
- Class II device experience
- R&D team leadership
- Product development pipeline management
- FDA regulations (21 CFR Part 820)
- ISO 13485
- ISO 14971
- Design control processes
- Risk management
- Cross-functional collaboration
Also useful
- 510(k) submission experience
- De Novo submission experience
- Usability engineering
- Consumer medical device experience
- Inspection readiness (FDA, notified bodies)
- Manufacturing and supply chain coordination
- KPI development and monitoring
- Product lifecycle optimization
About the Role
The VP, Medical Device Engineering will lead the strategy, team, and execution behind our regulated medical device portfolio - building the engineering foundation for a new generation of regulated consumer medical devices designed to make preventative care radically more accessible globally. This is a rare opportunity to shape a world-class device organization, owning everything from early concept through commercialization, while ensuring every product we ship meets the highest bar for safety, quality, compliance, and craftsmanship.
This leader will directly oversee medical device hardware product development and work cross-functionally with Quality, Regulatory Affairs, Clinical, and Manufacturing to bring products from concept to market with speed and rigor.
You Will: Business & Strategic Leadership
- Define and execute the strategic roadmap for the regulated devices portfolio, aligned with company growth objectives
- Own budgeting, and resource allocation for the regulated devices business unit * Partner with executive leadership to identify new product opportunities * Build and scale a high-performing, cross-functional organization
Product Development & R&D Leadership
- Directly lead R&D developing regulated medical devices from concept through design transfer and commercialization
- Ensure design control processes are robust, compliant, and efficiently executed (21 CFR Part 820, ISO 13485)
- Drive innovation while maintaining disciplined product development processes, including risk management (ISO 14971) and usability engineering
Quality & Regulatory Oversight
- Ensure all products meet FDA, international regulatory, and quality system requirements
- Partner closely with Quality and Regulatory leaders to support successful submissions (e.g., 510(k), De Novo as applicable)
- Champion a culture of quality and compliance across the organization * Ensure inspection readiness and successful audits (FDA, notified bodies, etc.)
Cross-Functional Leadership
- Provide indirect leadership and alignment across Clinical, Manufacturing, and Supply Chain
- Ensure clinical strategies support regulatory and commercial objectives
- Collaborate with Manufacturing/Operations to ensure scalable, cost-effective, and compliant production processes
Operational Excellence
- Establish and monitor KPIs across development, quality, regulatory, and manufacturing readiness
- Drive continuous improvement in product development lifecycle, time-to-market, and cost efficiency
- Identify and mitigate technical, regulatory, and operational risks
You Have
- Bachelor’s degree in Mechanical Engineering
- 15+ years of experience in the medical device industry, with significant experience in Class II devices
- Proven leadership experience overseeing R&D teams and product development pipelines
- Deep knowledge of FDA regulations, including 21 CFR Part 820, and international standards such as ISO 13485 and ISO 14971
- Demonstrated success leading products through regulatory clearance (e.g., 510(k)) and commercialization
- Experience working closely with Quality and Regulatory functions in a design controlled environment
Benefits
Our Benefits (There Are More but Here Are Some Highlights):
- Competitive salary & equity compensation for full-time roles
- Unlimited PTO, company holidays, and quarterly mental health days
- Comprehensive health benefits including medical, dental & vision, and parental leave
- Employee Stock Purchase Program (ESPP)
- 401k benefits with employer matching contribution
- Offsite team retreats
We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply-even if you're not sure if your background or experience is a perfect match.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
- If you need assistance or an accommodation due to a disability, please contact us at and describe the needed accommodation.
- Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation.
- Please do not send resumes to this email address.
About Hims & Hers
Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve.
Equal opportunity and legal notices
Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.
Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability.
From Hims & Hers's careers page, first listed on Rolev.ai on October 26, 2026. Rolev.ai is not the employer.
How Rolev.ai helps with this application
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Common questions
Where is the VP, Medical Device Engineering job at Hims & Hers located?
This VP, Medical Device Engineering position at Hims & Hers is located in Menlo Park, CA (On-site). Always check Hims & Hers's application page for specific state eligibility or relocation policies.
What qualifications are required for VP, Medical Device Engineering at Hims & Hers?
For the VP, Medical Device Engineering role, Hims & Hers highlights 15+ years of relevant experience; a bachelor's degree; experience with Medical device industry experience, Class II device experience, R&D team leadership, Product development pipeline management, FDA regulations (21 CFR Part 820), ISO 13485. Rolev.ai can score your existing resume against these requirements and show any skill gaps before you apply.
How do I apply for the VP, Medical Device Engineering position at Hims & Hers?
This listing links directly to Hims & Hers's Ashby application page. You can apply directly on Hims & Hers's site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the Ashby application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.