Staff / Senior Staff Sustaining Engineer | Medical Devices
I’m partnering with a commercial-stage medical device company to hire a Staff or Senior Staff Sustaining Engineer. You’ll be the technical lead keeping a commercial disposable device line reliable, manufacturable and performing well in the field.
THE ROLE
You’ll own complex product issues end to end: complaints, CAPAs, field problems, supplier and material changes, and manufacturing issues. You’ll lead each one from root cause through closure, working across Quality, Manufacturing, Regulatory, Supply Chain and R&D. The environment moves fast and priorities can shift quickly, so you’ll need to be comfortable reprioritizing while keeping ownership.
RESPONSIBILITIES
Lead sustaining engineering for commercial products Investigate and resolve complaints, field issues, manufacturing problems and customer escalations Lead CAPA, root-cause analysis, corrective actions and effectiveness checks Evaluate and implement material, component, supplier and process changes, including risk assessment and V&V Drive biocompatibility, sterility and sterile barrier testing, coordinating with external test labs Perform design verification, design validation and process validation, and prepare documentation for regulatory submissions Analyze complaint, manufacturing and field data to spot trends early Support product improvements, cost reductions, supply continuity and obsolescence management Maintain specifications, drawings, risk files and test methods Mentor engineers and guide cross-functional teams
QUALIFICATIONS
BS or higher in Mechanical, Biomedical, Materials, Manufacturing or related engineering 8+ years of experience for Staff, 10+ for Senior Staff Broad sustaining, product, manufacturing or quality engineering experience on commercial products Strong track record with CAPA, root-cause investigations, complaints and field issues Experience implementing material, supplier or process changes Proven ability to lead cross-functional issues to closure Experience in a regulated development or manufacturing environment
PREFERRED
Disposable or single-use medical device experience ISO 13485, FDA QSR, design controls and risk management Polymers, adhesives, molded components, assemblies or packaging Product or mechanical design background Statistical methods and data analysis