VP, Medical Device Engineering

Hims & Hers•Menlo Park, CA

13d•$340,000 - $380,000

About The Position

Hims & Hers is hiring a VP, Medical Device Engineering to lead the strategy, team, and execution for its regulated medical device portfolio. The role will build the engineering foundation for a new generation of regulated consumer medical devices intended to make preventative care more accessible globally, owning development from early concept through commercialization and ensuring products meet high standards for safety, quality, compliance, and craftsmanship. The VP will directly oversee medical device hardware product development and work across Quality, Regulatory Affairs, Clinical, Manufacturing, and Supply Chain. The leader will define the portfolio roadmap, manage budgeting and resource allocation, build a high-performing organization, and guide R&D through design transfer and commercialization. They will also ensure robust design controls, regulatory and quality compliance, inspection readiness, operational excellence, and scalable, cost-effective production.

Requirements

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, such as 510(k), and commercialization.
Experience working closely with Quality and Regulatory functions in a design-controlled environment.

Responsibilities

Define and execute the strategic roadmap for the regulated devices portfolio in alignment 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.
Lead R&D developing regulated medical devices from concept through design transfer and commercialization.
Ensure design control processes are robust, compliant, and efficiently executed, including compliance with 21 CFR Part 820 and ISO 13485.
Drive innovation while maintaining disciplined product development processes, including risk management and usability engineering.
Ensure products meet FDA, international regulatory, and quality system requirements.
Partner with Quality and Regulatory leaders to support successful regulatory submissions, such as 510(k) and De Novo submissions as applicable.
Champion a culture of quality and compliance across the organization.
Ensure inspection readiness and successful audits by the FDA, notified bodies, and others.
Provide indirect leadership and alignment across Clinical, Manufacturing, and Supply Chain.
Ensure clinical strategies support regulatory and commercial objectives.
Collaborate with Manufacturing and Operations to ensure scalable, cost-effective, and compliant production processes.
Establish and monitor KPIs across development, quality, regulatory, and manufacturing readiness.
Drive continuous improvement in the product development lifecycle, time-to-market, and cost efficiency.
Identify and mitigate technical, regulatory, and operational risks.