NPI Process Development Engineer

Natus Neuro Process Development Engineer

For more than 80 years, Natus has been working in collaboration with clinicians to deliver industry-leading neuro solutions that help providers more easily make sense of the body’s signals. Engineered with input from those who have lived the care experience, our technology simplifies complex processes and improves accuracy and efficiency. There is a role for everyone who wants to be part of the innovative solutions at Natus Neuro.

Location: Hybrid Role in Middleton, WI (Must be able to go into the office 2-3 days a week)

About the Role

The NPI Process Development Engineer plays a critical role in bridging R&D design intent with robust, scalable, and compliant manufacturing processes for electromechanical medical devices. This engineer partners closely with Electrical, Mechanical, Systems, and Operations teams to ensure smooth transition from prototype to pilot to full production. This role requires strong technical depth in DFM, DFA, DFT, process validation (IQ/OQ/PQ), and supplier process readiness, as well as hands-on experience developing and validating manufacturing processes for complex electro-mechanical assemblies.

Key Responsibilities

1. New Product Introduction (NPI) & Process Development
2. Lead NPI activities for electromechanical devices from engineering build through launch.
3. Translate design intent into scalable and robust manufacturing processes.
4. Own development of assembly processes, line layouts, tooling requirements, and work instructions.
5. DFM / DFA / DFT Ownership
6. Drive DFM/DFA/DFT assessments during each design phase.
7. Conduct structured reviews with Electrical, Mechanical, and Systems Engineering teams.
8. Provide actionable feedback to improve manufacturability, testability, yield, and cost.
9. Ensure manufacturability risks are captured in design reviews, 8Ds, and risk management files.
10. Build Plan Creation & Execution
11. Create detailed build plans for EVT, DVT, PVT/PV, Beta, and Production readiness builds.
12. Work with R&D hardware and product development teams to align build quantities, configurations, supplier capabilities, and timeline.
13. Execute builds at suppliers and in-house, ensuring proper traceability, documentation, and process controls.
14. Process Validation (IQ/OQ/PQ)
15. Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for manufacturing processes both internally and at suppliers.
16. Guide suppliers through validation protocol creation, execution, and documentation.
17. Ensure processes comply with FDA, ISO 13485, IEC 60601, and internal quality system requirements.
18. Supplier Technical Management
19. Work directly with contract manufacturers, PCB assemblers, mechanical fabricators, and component suppliers.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability.