Search Overview
A Class III medical device manufacturer had FDA compliance problems in its product development quality engineering. It needed a VP of Operations to put ISO 13485 processes in place and run site-level production. The job meant leading hardware and firmware engineering teams, modernizing quality systems under FDA scrutiny, and rebuilding quality processes while production of life-critical devices kept running.
Talent Landscape
Hiring Criteria
The profile required all of these together.
Few executives have all three: Class III medical device operations, leadership of hardware and firmware engineering teams, and quality systems built or restructured under FDA/ISO audit.
Key Insights
Class III Medical Device Operations
Life-critical devices (perfusion systems, surgical equipment, critical monitoring) get the closest regulatory scrutiny. Candidates needed to have run operations where a quality failure puts a patient at risk right away. That is a different risk profile from Class I/II devices.
Hardware + Firmware Engineering Leadership
The VP would lead hardware and firmware engineers through product development cycles. Candidates needed to speak both languages: PCB design constraints and embedded systems architecture.
ISO 13485 Quality Systems Expertise
Candidates needed hands-on experience building or restructuring quality engineering processes under FDA audit. The company's FDA issues called for someone who could build quality steps into product development and make them stick.
Inside the Search
The Regulatory Context
The company was rebuilding product development quality processes under ISO 13485 while already under FDA scrutiny. Candidates needed to have answered FDA observations, carried out corrective actions, and set up quality engineering practices that held.
Qualification Breakdown
- 31 executives with operations leadership in Class III medical device manufacturing
- 17 had built or restructured quality systems under FDA/ISO audit conditions
- 12 had led hardware and firmware engineering teams through regulatory cycles
- 6 met leadership capability, compensation expectations, and geographic requirements
Outcome & Track Record
The hired VP of Operations had brought multiple Class III products to market, from design controls through commercial launch. They had modernized quality processes in similar FDA response situations while leading hardware, firmware, quality, and regulatory teams.
Critical Success Factors
- Systems Thinking: Diagnoses root causes in quality systems
- Lean Transformation Experience: Has driven operational improvement during scale-up
- Team Alignment: Gets engineering, quality, and regulatory teams working together
- Site Authority: Wants decision-making autonomy and direct board interaction
- Regulatory Resilience: Comfortable under FDA scrutiny while production keeps running
Candidate Motivations
What drew the top candidates:
- Rebuilding quality systems with executive sponsorship
- A Midwest location with a lower cost of living than the Boston and California medtech hubs
- Site-level authority over operations, quality, and engineering
- Keeping production running while making regulatory improvements
- The patient-safety stakes of life-critical devices