Location: 01752, Marlborough, Massachusetts, United States
Duration: 6 months + extension
Job description:
Long lasting experience (e.g. 7+ years) primarily in Design Verification and Validation of processes with emphasis on new part development. Developing and manufacturing plastic disposable kit products for a regulated industry (preferred medical device, class II and/or class III). Mater's degree or equivalent experience in related engineering or scientific fields (mechanics, micro-mechanics, materials...).
Well-founded knowledge and practical experience of relevant regulations (ISO13485, ISO11607, FDA 21 CFR Part 820), specifically for the US and European market product submission.
Demonstrated experience in defining and managing Design Verification and Validation plans, test execution, results risk mitigation, statistical data analysis and reports.
Experience in Design V&V activities related to disposable kits for medical device application associated to manufacturing processes such as injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding.
Hands-on experience with expertise in test method validation (e.g. DOE, OQ, Gage R&R), Design Verification & Validation, mechanical testing (e.g. pull/peel test, burst test, leak test, dye test, bubble test...), packaging design, transportation conditions simulation (e.g. ISTA) and stability study (e.g. pre-conditioning, aging test...).