Sr. Design Quality Engineer
Core
Develop and evaluate designs for medical devices to ensure they meet product requirements, are optimized for manufacturability and reliability, and comply with FDA and EU MDR regulations.
Role type
Senior Design Quality Engineer
Builds
Medical device products compliant with global regulatory expectations
Domain
Medical Devices / Quality Engineering
Required skills
DMAIC, Minitab, DOE, SPC, FMEA, ISO 14971, A3 thinking, PDCA, QMS processes, FDA 21 CFR Part 820, ISO 13485, IQ/OQ/PQ, CAPA, RCA, PSUR, CER, TD files, PPAP
Preferred skills
Lean sigma, 5S, Statistical methods (ANOVA, t-test, regression), Problem solving techniques
Technologies
Minitab, MS Project
Responsibilities
Develop and evaluate designs meeting medical device product requirements; Verify product design functionality using design test methodology; Utilize project management and lean sigma methodologies; Conduct QMS processes including CTQ identification; Evaluate products and process risks using FMEA; Execute Process Qualification (IQ, OQ, PQ); Leverage CAPA with RCA to solve problems; Develop and maintain PSURs, CERs, and Technical Documentation; Collaborate with cross-functional teams to ensure compliance; Comply with PPAP requirements documentation.
Seniority
Senior, hands-on IC