Design Verification and Validation Engineer - Sunrise Systems, Inc.

Our client, a leading medical devices company, is looking for a Design Verification and Validation Engineer. This is for an initial duration of 9 months and is located in Marlborough, MA.

(Candidates must be able to work on W2 without VISA sponsorship)

3 must haves

• Test method validation/GageR&R
• Design Verification and Validation
• Statistical Data analysis

Requirements:

• 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).
• Master’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...).
• Strong organizational and communication skills in multisite, multidisciplinary, multicultural matrix organization. Fluent in written and spoken English. Self-starter, hands-on, creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.