Job Description
We are seeking a skilled and proactive Product Validation Engineer. The ideal candidate will support tooling and production validation activities to ensure products meet performance, reliability, and regulatory requirements. This includes development and execution of validation protocols, support for process qualifications, and ownership of PPAP documentation.
How you will make an impact as a Product Validation Engineer:
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.Skills you will need to be successful:
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.Preferred Experience:
Medical qualification.
Manufacturing processes: injection molding, MIM, die cast, sheet metal, PCBAs.
Work with suppliers and contract manufacturers.
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
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Full-time