Engineering - Engineer - Test; Senior Level

Job Title

Job Description:

100% onsite yes, USA - Marlborough Results Way;
Mon-Fri 8am-5pm

3 Must Haves:

• Test method validation
• Verification and Validation
• Data analysis

What You Will Do:

• Derive test requirements from the specifications, define test plan and methodology, estimate effort and resources plan to cover design verification and validation campaign.
• Establish acceptance criteria, sampling, assess through modelling or qualitative/quantitative testing, evaluate the performance according to URS, SRS (design inputs and outputs).
• Write test protocol, setup design of experiments, execute tests, analyze results and document report for design verification and validation activities with focus on quality, compliance and execution rigor.
• Mitigate project technical risks, resolve issues, deliver on-time and communicate effectively.
• Perform Test Method Validation and Equipment Qualification.
• Lead root cause analysis, investigations on test failures through Verification & Validation activities.
• Develop good practice guidelines for performing disposables kit verification and validation activities and organize standardization and harmonization within the Disposables & Materials Engineering Team.

Who You Are:

• 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).
• 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 (ISO
  13485, 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...).
• 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.