VP, Medical Device Engineering

The role

The VP, Medical Device Engineering will lead the strategy, team, and execution for a regulated medical device portfolio. This leader will oversee hardware product development from concept through commercialization while working cross-functionally with Quality, Regulatory, Clinical, and Manufacturing.

What you will do

• Define and execute the strategic roadmap for the regulated devices portfolio
• 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
• Lead R&D developing regulated medical devices from concept through design transfer and commercialization
• Ensure design control processes are robust, compliant, and efficiently executed
• Drive innovation while maintaining disciplined product development processes
• Ensure all products meet FDA, international regulatory, and quality system requirements
• Partner with Quality and Regulatory leaders to support successful submissions
• Establish and monitor KPIs across development, quality, regulatory, and manufacturing readiness

Required qualifications

• Bachelor’s degree in Mechanical Engineering
• 15+ years of experience in the medical device industry
• 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
• Knowledge of 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

• Competitive salary & equity compensation
• Unlimited PTO
• Company holidays
• Quarterly mental health days
• Comprehensive health benefits including medical, dental & vision
• Parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

About the company

Hims & Hers is a health and wellness platform that provides access to personalized care. It is a public company traded on the NYSE under the ticker symbol HIMS.