VP, Regulated Device Engineering

About the role

The VP, Regulated Device Engineering is responsible for the overall leadership, strategy, and execution of the company’s regulated medical device business organization. This role owns end-to-end product development, from concept through commercialization, ensuring compliance with all FDA and global regulatory requirements while driving innovation, quality, and operational excellence.

Responsibilities

• 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
• 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
• 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.)
• Provide indirect leadership and alignment across Clinical, Manufacturing, and Supply Chain
• Collaborate with Manufacturing/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 product development lifecycle, time-to-market, and cost efficiency
• Identify and mitigate technical, regulatory, and operational risks

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 (e.g., 510(k)) and commercialization
• Experience working closely with Quality and Regulatory functions in a design controlled environment

Qualifications

• Proven track record of leading complex projects and managing cross-functional teams
• Strong understanding of medical device regulations and standards
• Excellent communication and interpersonal skills
• Ability to manage multiple priorities and deadlines effectively
• Experience with project management tools and methodologies

Skills

• Strategic thinking and planning
• Product development and innovation
• Regulatory compliance and risk management
• Leadership and team management
• Project management and process improvement

Benefits

• 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

Pay

Competitive salary and equity compensation for full-time roles.

Schedule

Full-time position.