Product Validation Engineer
- Manchester, NH
- Permanent
- Full-time
- Support validation efforts for new products, including development and execution of IQ/OQ/PQ protocols.
- Manage PPAP submissions in collaboration with Quality, Engineering, and Suppliers.
- Support new product introductions (NPI) with validation plans aligned to project milestones.
- Collaborate with cross-functional teams to define and document critical-to-quality characteristics (CTQs) and validation acceptance criteria.
- Develop test methods, fixtures, and procedures for functional and durability testing of mechanical and electromechanical components.
- Analyze test results, investigate failures, and drive corrective actions.
- Apply statistical tools and methods (e.g., GR&R, capability analysis, DOE) to support validation and continuous improvement.
- Maintain detailed records and documentation to ensure compliance with internal quality systems and industry standards.
- Participate in supplier validation activities and support audits as needed.
- Bachelor’s degree in Mechanical, Industrial, or Manufacturing Engineering or a related field.
- 2+ years of experience in a manufacturing or product validation role (preferably in a regulated or high-reliability industry).
- Strong knowledge of validation processes, including PPAP, PFMEA, control plans, and MSA.
- Familiarity with statistical analysis tools (e.g., Minitab) and GD&T.
- Hands-on experience with testing mechanical assemblies and root cause analysis techniques.
- Solid understanding of lean manufacturing principles and continuous improvement.
- Strong communication and technical documentation skills.
- Medical qualification.
- Manufacturing processes: injection molding, MIM, die cast, sheet metal, PCBAs.
- Work with suppliers and contract manufacturers.