Job Title: Validation Engineer

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...).