Sr. Design Quality Engineer
Core
Develop and evaluate medical device designs for manufacturability, reliability, and cost; verify functionality through design test methodology and specifications.
Role type
Senior Design Quality Engineer
Builds
Medical device products compliant with FDA and EU MDR regulations
Domain
Medical Devices / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
DMAIC, Minitab, DOE, SPC, FMEA, ISO 14971, QMS processes, FDA 21 CFR Part 820, ISO 13485, IQ/OQ/PQ, CAPA, RCA, PPAP
Preferred skills
Lean Sigma, Value Stream Mapping, 5S, A3 thinking, PDCA, PSUR, CER, Technical Documentation
Technologies
Minitab, MS Project
Responsibilities
Develop design test methodology and specifications; Evaluate product and process risks using FMEA; Conduct QMS processes including CTQ identification; Execute Process Qualification (IQ/OQ/PQ); Collaborate with cross-functional teams for regulatory compliance; Troubleshoot production issues using problem-solving techniques.
Seniority
Senior, hands-on IC
