Validation Specialist

Tax Work Location: USA – Marlborough, MA

Job Title: Engineering - Engineer - Verification and Validation RD (Mid Level)

What you will do:

• Lead and execute Verification and Validation (V&V) activities for disposable kit development.

• 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.

• Develop best practice guidelines for performing disposables kit Verification & Validation activities and champion standardization and harmonization within the R&D team.

• 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).

• Advise R&D team members on execution of process validation (IQ/OQ/PQ) activities and metrology best practices.

• 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.

Who you are:

•Bachelor’s degree or equivalent in related engineering or scientific fields (mechanics, micro-mechanics, materials...). Long lasting experience (e.g. 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.

• Expertise in test method validation (e.g. 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. ISTA) and stability study (e.g. pre-conditioning, aging test,...).

• 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.

Thanks