Sustaining Engineer
Duluth
Permanent
$100,000 - $120,000 USD a year
Research and Development
PR/598572_1786987693
Sustaining Engineer
Sustaining Engineer | Medical Device Industry
Join a growing medical device company where you'll play a key role in supporting and improving products that make a real impact on patient care. This is a highly visible position offering exposure to product development, manufacturing, quality, regulatory, and supplier management activities.
What You'll Do
- Drive product improvements through design changes, V&V testing, and engineering analysis.
- Own sustaining engineering projects, change controls, and DHF/technical documentation updates.
- Investigate product and manufacturing issues, lead root cause analysis, and support CAPA activities.
- Partner with suppliers and manufacturing teams to manage component obsolescence and improve product reliability.
- Support global regulatory submissions through testing, technical documentation, and compliance activities.
What We're Looking For
- BS in Engineering (Biomedical, Mechanical, Electrical, Manufacturing, or similar).
- 2+ years of engineering experience in a regulated industry, preferably medical devices.
- Experience with design controls, V&V, change management, CAPA, and technical documentation.
- Knowledge of FDA regulations, ISO 13485, and product lifecycle management.
Why Consider This Opportunity?
- Broad technical ownership and visibility.
- Direct impact on product quality and innovation.
- Cross-functional collaboration with engineering, quality, manufacturing, and regulatory teams.
- Excellent opportunity for career growth in the medical device industry.
