Senior Design Quality Engineer (Mechanical)
Core
Execute and own quality engineering activities for mechanical workstreams in new product development, ensuring safety, reliability, and manufacturability of medical devices.
Role type
Senior Design Quality Engineer (Mechanical)
Builds
Medical device components and assemblies
Domain
Medical device manufacturing / Mechanical engineering
Required skills
Risk management, Design verification and validation, Process controls, Design transfer, PPAP execution, Statistical analysis, FMEA, GD&T, Root cause analysis, CAD interpretation, Polymer material knowledge
Preferred skills
ISO 13485 and ISO 14971 knowledge, Six Sigma or ASQ certification, Minitab, Mistake Proofing/Poka-Yoke
Technologies
Minitab, CAD
Responsibilities
Partner with R&D to evaluate mechanical product designs against quality requirements; Own risk management deliverables including plans and reviews; Execute design quality activities across requirements, reviews, and change control; Develop and execute design verification and validation strategies; Partner with Operations to implement manufacturing process controls; Coordinate product design and quality transfers including PPAP; Identify and document critical quality attributes using risk-based methods; Support quality system maintenance and improvement.
Seniority
Senior, hands-on IC