Manufacturing Quality Engineer; Medical Devices

Qualifications

• Under limited supervision, performs and documents moderately complex technical functions relating to requirements mapping, test matrices, DOE, environments, corner cases etc.,
• Experience in validation of products and equipment in the medical industry.
• Knowledge of APQP/PPAP, Design Characterization Plan, DVP&R, DV/PV, DOE, DFMEA
• Experience with Manufacturing/Process Engineering on DFM/DFA.
• Knowledge of ISO 13485, FDA 21 CFR Part 820 and GMP.

• Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Client's procedures and guidelines, the duties and responsibilities for this position are:
• Build and own the Design Characterization Plan (requirements mapping, test matrices, DOE, environments, corner cases).
• Create and maintain DVP&R; execute DV/PV, summarize results, and drive issue closure.
• Develop/qualify test methods and fixtures; perform MSA/GR&R and lab correlation (prototype ↔ production).
• Analyze data using statistical tools (DOE, regression, capability, tolerance stacks) and define design limits
• Partner with Manufacturing/Process Engineering on DFM/DFA, process windows, and transfer-to-production.