Senior Validation Engineer

We are hiring for our client in the Medical Device Industry.

Duration: 5 months contract (Extendable)

Job Type: 100 % onsite

Responsibilities:

• 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.
• Derive test requirements from specifications, define test plans and methodologies, estimate effort, and resource plans to cover design verification and validation campaigns.
• Establish acceptance criteria, sampling sizes, assess through modeling or qualitative/quantitative testing, and evaluate performance according to URS, SRS (design inputs and outputs).
• Develop good practice guidelines for performing disposable kit verification and validation activities and organize standardization and harmonization within the R&D disposables team.
• Mitigate project technical risks, resolve issues, deliver on-time, and communicate effectively.

Requirements/Skills:

• Master’s degree or equivalent in related engineering fields (mechanical, materials, etc.).
• Minimum 5 years of experience in designing, developing, and manufacturing plastic disposable kit products for regulated industries (medical devices, class II and/or class III).
• Well-founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for US and European market product submission.
• Demonstrated experience in defining and managing verification and validation plans, execution, statistical data analysis, and reporting.
• Experience in verification 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, and solvent bonding.