Senior Validation Engineer - Katalyst Healthcares & Life Sciences

• Derive test requirements from the design specifications, define test plan and methodology, estimate effort and resources plan to cover design verification and validation campaign. Establish acceptance criteria, sampling, assess through modeling or qualitative/quantitative testing, evaluate the performance according to URS, SRS (design inputs and outputs).

• Write test protocol, setup design of experiments, execute tests, analyse results and document reports for design verification and validation activities with a 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, and 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.

Requirements:

• Master's degree or equivalent experience in related engineering or scientific fields (mechanics, micro-mechanics, materials...).

• 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).

• 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 designing 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), 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 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.