Located in the vibrant city of Marlborough, USA, this role offers the opportunity to work 100% onsite at our Results Way facility.
Enjoy a dynamic work environment from Monday to Friday, 8am-5pm, where innovation and excellence are at the forefront.
Key Responsibilities Derive test requirements from specifications, define test plans and methodologies, and estimate effort and resources to cover design verification and validation campaigns. Write test protocols, set up design experiments, execute tests, analyze results, and document reports for design verification and validation activities with a focus on quality, compliance, and execution rigor. Perform Test Method Validation and Equipment Qualification. Lead root cause analysis and investigations on test failures through Verification & Validation activities. Develop guidelines for performing disposables kit verification and validation activities and organize standardization and harmonization within the Disposables & Materials Engineering Team. Qualifications At least 7 years of experience in Verification and Validation of processes, particularly in new part development and manufacturing of 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, etc.
). 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 applications associated with 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). Strong organizational and communication skills in a 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. #TB_EN