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.

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)

VP, Medical Device Engineering

Responsibilities

Qualification

Required

Benefits

Company

Hims and Hers

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