VP, Regulated Device Engineering

Responsibilities

• Define and execute the strategic roadmap for the regulated devices portfolio in alignment with company growth objectives
• Lead R&D efforts to develop regulated medical devices from initial concept through design transfer and commercialization
• Oversee budgeting, resource allocation, and the scaling of a high-performing, cross-functional organization
• Ensure robust and compliant design control processes, including risk management (ISO 14971) and usability engineering
• Partner with Quality and Regulatory leaders to support successful submissions such as 510(k) and De Novo
• Drive operational excellence by establishing KPIs across development, quality, and manufacturing readiness
• Collaborate with Manufacturing and Supply Chain to ensure scalable, cost-effective, and compliant production processes

Requirements

• Bachelor’s degree in Mechanical Engineering
• 15+ years of experience in the medical device industry, specifically with Class II devices
• Proven leadership experience overseeing R&D teams and complex product development pipelines
• Deep knowledge of FDA regulations (21 CFR Part 820) and international standards (ISO 13485 and ISO 14971)
• Demonstrated success leading products through regulatory clearance and full commercialization
• Experience working within a highly disciplined, design-controlled environment

Benefits

• Competitive salary and equity compensation
• 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

About the Company

Hims & Hers is a 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 delivering affordable, accessible, and personalized care from diagnosis to treatment to delivery. As a public company traded on the NYSE, we are innovating on health and wellness solutions to make better outcomes easier to achieve.