VP, Medical Device Engineering

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.

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)

Champion a culture of quality and compliance across the organization • Ensure inspection readiness and successful audits (FDA, notified bodies, etc.)

Cross-Functional Leadership

Provide indirect leadership and alignment across Clinical, Manufacturing, and Supply Chain

Ensure clinical strategies support regulatory and commercial objectives

Collaborate with Manufacturing/Operations to ensure scalable, cost-effective, and compliant production processes

Operational Excellence

Establish and monitor KPIs across development, quality, regulatory, and manufacturing readiness

Drive continuous improvement in product development lifecycle, time-to-market, and cost efficiency

Identify and mitigate technical, regulatory, and operational risks

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 (e.g., 510(k)) and commercialization

Experience working closely with Quality and Regulatory functions in a design controlled environment

Competitive salary & equity compensation for full-time roles

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

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.

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