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Senior Validation Engineer

2 months ago

Marlborough, United States ProKatchers LLC Full time

Job Title : Senior Validation Engineer

Location : Marlborough, MA 01752

Duration : 10 Months

Job Description :

  • Long lasting experience (e.g. 7+ years) in 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).
  • Well-founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for the US and European market product submission.
  • Demonstrated experience in defining and managing Verification and Validation plans, test execution, results risk mitigation, statistical data analysis and reports.
  • Experience in 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), 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)