VP, Medical Device Engineering

hims & hers; Menlo Park (CA); On-site; USD 350,000 - 600,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO

Comprehensive health benefits

Employee Stock Purchase Program (ESPP)

401k with employer matching

Offsite team retreats

Job summary

Hims & Hers is seeking a VP, Medical Device Engineering to lead strategy, the team, and execution for our regulated medical device portfolio, building the engineering foundation for a new generation of consumer devices designed to make preventative care globally accessible.

This leader will oversee hardware development and collaborate with Quality, Regulatory Affairs, Clinical, and Manufacturing to bring concepts to market with speed and rigor, ensuring every product meets safety, quality, and

Qualifications

• Bachelor’s degree in Mechanical Engineering.
• 15+ years in the medical device industry with Class II devices.
• Proven leadership overseeing R&D teams and product development pipelines.
• Deep knowledge of FDA regs (21 CFR Part 820) and ISO 13485/14971.
• Experience leading regulatory clearance (e.g., 510(k)) and commercialization.

Responsibilities

• Define and execute the strategic roadmap for regulated devices.
• Direct R&D from concept through design transfer and commercialization.
• Ensure robust design controls and regulatory compliance.
• Partner with Quality/Regulatory to support submissions (510(k), De Novo).
• Lead cross-functional collaboration with Clinical, Manufacturing, and Supply Chain.

Skills

R&D leadership

Regulatory knowledge

FDA regulations

Quality collaboration

Education

Bachelor’s degree in Mechanical Engineering

Job description

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.

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent‑first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.

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

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.

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.

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.

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.

To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.