VP, Regulated Medical Device Engineering & Innovation

K1 Industries; 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 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