Director Operations Engineering
$170,000–$240,000 year
On-siteMinneapolis, Minnesota, United States
Job Summary
Develop and execute engineering strategy aligned with the company's manufacturing roadmap, leading a high-performing team across product development, sustaining engineering, and technical operations. Oversee all engineering activities from concept to commercialization while managing contract manufacturer relationships, supplier quality, and design transfer readiness. Drive process validation, DFM/DFA efforts, and root cause analyses to ensure compliance with FDA QSR, ISO 13485, and IEC 60601 standards. Build scalable systems, documentation, and design controls to support the organization's expansion into an increased manufacturing footprint.
Required Qualifications
- Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related field
- Master's degree
- 10+ years of engineering experience in the medical device industry
- 5+ years in technical leadership roles, managing cross-functional engineering teams
- Proven success leading Sustaining Engineering and/or NPD programs under regulated design controls
- Experience working with contract manufacturers and leading design transfer activities
- Strong understanding of FDA 21 CFR Part 820, ISO 13485, risk management (ISO 14971), and V&V methodologies
- Demonstrated ability to build processes, mentor teams, and drive cross-functional alignment
Desired Qualifications
- Experience in scaling manufacturing capabilities, including equipment procurement, process development, and validation
- Background in complex electromechanical systems, wearable devices, diagnostics, or therapeutic devices
- Strong systems engineering and root‐cause problem‐solving skills
- Experience in a growth-stage or transformation-stage environment
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.