Product Engineer

Basic Qualifications:       

Master’s degree in Mechanical, Industrial or Biomedical engineering or related engineering field and 6 months experience as a product or quality engineer in the medical device industry; Or, Bachelor’s degree in Mechanical, Industrial or Biomedical engineering or related engineering field and 2 years’ experience as a product or quality engineer in the medical device industry. Must possess at least 6 months experience with each of the following: Medical device Complaint Handling, Service Monitoring, and Audit; Test Method, Equipment and Tooling Validation; DMAIC, Root Cause Analysis, CAPA and PFMEA; IQ/OQ/PQ and process changes; GD&T, Gage R&R, MSA, statistical analysis, and Minitab; MES, Enovia, Trackwise, and Agile QMS; cGMPs, cGDPs, and FDA QSR; FDA 21 CFR Parts 11, 210, 820, and ISO 9001, ISO 13485 and ISO 14971

Relocation assistance not available for this position.

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