About the Role: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.
You Will: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)
- 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
You Have:- 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
Our Benefits (there are more but here are some highlights):- 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
