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
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