VP, Regulated Device Engineering (Medtech)

TL;DR

VP, Regulated Device Engineering (Medtech): Leading the strategy and execution of the regulated medical device business with an accent on end-to-end product development and global regulatory compliance. Focus on scaling a high-performing R&D organization, managing FDA submissions, and ensuring operational excellence from concept to commercialization.

Location: On-site in Minnetonka, Minnesota (US-based candidates)

Salary: $300,000 – $350,000 + Equity

Company

hirify.global is a leading health and wellness platform redefining healthcare by providing affordable, accessible, and personalized care from diagnosis to delivery.

What you will do

• Define and execute the strategic roadmap for the regulated devices portfolio aligned with growth objectives.
• Lead R&D for regulated medical devices from concept through design transfer and commercialization.
• Ensure design control processes are robust and compliant with 21 CFR Part 820 and ISO 13485.
• Partner with Quality and Regulatory leaders to support successful FDA submissions (e.g., 510(k), De Novo).
• Provide cross-functional alignment across Clinical, Manufacturing, and Supply Chain teams.
• Establish and monitor KPIs to drive continuous improvement in the product development lifecycle.

Requirements

• Bachelor’s degree in Mechanical Engineering.
• 15+ years of experience in the medical device industry, specifically with Class II devices.
• Proven leadership experience overseeing R&D teams and product development pipelines.
• Deep knowledge of FDA regulations (21 CFR Part 820) and international standards (ISO 13485, ISO 14971).
• Demonstrated success leading products through regulatory clearance (510(k)) and commercialization.
• Must be based in the United States.

Culture & Benefits

• Competitive salary and equity compensation.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive health benefits including medical, dental, vision, and parental leave.
• 401k benefits with employer matching contribution and Employee Stock Purchase Program (ESPP).
• Offsite team retreats.