Design Verification Engineering

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Define test plans, methodology, test equipment, and resources to support design Verification and Validation activities.
Set-up design of experiments (DOE) and/or review plan and results to support product evaluation and process development.
Establish acceptance criteria and sampling plans through statistical analysis or qualitative and quantitative testing.
Perform and document technical root cause investigations in collaboration with R&D hardware, software, application, manufacturing, biology, and disposable kit system matter experts (SMEs).
Support Risk Analysis activities within the R&D team and contribute to product Risk Management File (RMF).
Support R&D supplier capability and quality audits.
Mitigate project technical risks, resolve issues, deliver on-time, and establish strong communications with internal and external stakeholders.
Assess product specifications and change control documentation for improving the manufacturing of new and existing devices.
Support R&D team in developing supplier quality plans, supplier specifications and defining CTQ requirements.
Bachelor’s degree or equivalent in related engineering or scientific fields (mechanics, micro-mechanics, materials...). 6-10+ years) in designing, developing and manufacturing plastic disposable kit products for a regulated industry (e.g. medical device, class II and/or class III).
Experience in verification 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.
DOE, OQ, Gage R&R), mechanical testing (e.g. pull/peel test, burst test, leak test, dye test, bubble test,...), in packaging design, transportation conditions simulation (e.g. Familiar with disposable product manufacturing processes such as injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding and ISO class 7 & 8 cleanroom operations.
Knowledge of materials biocompatibility (ISO 10993 and USP 88), leachable & extractable (E&L) evaluations and sterilization techniques is a plus.
Experience with medical device risk management and risk analysis (ISO 14971).
Knowledge of statistical data analysis, methods, and tools (Minitab or equivalent).
Experience with test method validation (TMV), Gage R&R and process capability analysis.
Employment type Contract
Job function Manufacturing
Industries Manufacturing

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