NPI Process Development Engineer

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

• Lead NPI activities for electromechanical devices from engineering build through launch.
• Translate design intent into scalable and robust manufacturing processes.
• Own development of assembly processes, line layouts, tooling requirements, and work instructions.

2. DFM / DFA / DFT Ownership

• Drive DFM/DFA/DFT assessments during each design phase.
• Conduct structured reviews with Electrical, Mechanical, and Systems Engineering teams.
• Provide actionable feedback to improve manufacturability, testability, yield, and cost.
• Ensure manufacturability risks are captured in design reviews, 8Ds, and risk management files.

3. Build Plan Creation & Execution

• Create detailed build plans for EVT, DVT, PVT/PV, Beta, and Production readiness builds.
• Work with R&D hardware and product development teams to align build quantities, configurations, supplier capabilities, and timeline.
• Execute builds at suppliers and in-house, ensuring proper traceability, documentation, and process controls.

4. Process Validation (IQ/OQ/PQ)

• Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for manufacturing processes both internally and at suppliers.
• Guide suppliers through validation protocol creation, execution, and documentation.
• Ensure processes comply with FDA, ISO 13485, IEC 60601, and internal quality system requirements.

5. Supplier Technical Management

• Work directly with contract manufacturers, PCB assemblers, mechanical fabricators, and component vendors.
• Conduct on-site process audits, capability assessments, and readiness reviews.
• Drive supplier alignment on process parameters, test fixtures, tooling, and documentation.
• Troubleshoot supplier issues related to yield, test, soldering/assembly, electro-mechanical integration, etc.

6. Manufacturing Test Development

• Support Electrical and Test Engineering to define and refine DFT, ICT/functional test requirements, and in-line inspection steps.
• Ensure test strategies align with product requirements and manufacturing constraints.

7. Cross-Functional Collaboration

• Work with Program Management, Quality Engineering, Product Development, Hardware, Firmware, and Ops to ensure smooth handoffs at each NPI milestone.
• Support MRB/NCR investigations and root-cause analysis for electromechanical issues.
• Contribute to ECOs, validation reports, process FMEAs, and risk files as part of the design control process.

Qualifications

Required

• Bachelor's degree in Mechanical, Electrical, Manufacturing, or related engineering field.
• 5+ years of experience in NPI, Process Development, or Manufacturing Engineering-preferably in medical devices or regulated electro-mechanical products.
• Strong hands-on experience with DFM, DFA, DFT for mixed electro-mechanical assemblies.
• Proven experience developing and validating processes using IQ/OQ/PQ frameworks.
• Experience working directly with suppliers/CMs (PCBA, plastics, metals, electro-mechanical assemblies).
• Strong understanding of FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601 and related quality/regulatory standards.
• Ability to interpret schematics, BOMs, Gerber files, mechanical drawings, test logs, and process flow diagrams.

Preferred

• Experience with EEG, wearable medical devices, or other neurodiagnostic systems.
• Knowledge of PCBA troubleshooting, ICT/functional test fixtures, SMT/TH processes.
• Experience participating in or leading PFMEA/DFMEA, control plan creation, and lean manufacturing initiatives.
• Prior experience with global manufacturing transfer (China/Europe/Vietnam preferred).

Key Skills

• Strong problem-solving and root-cause analysis
• Excellent communication and supplier-management skills
• Ability to work in fast-paced, high-complexity R&D environments
• Detail-oriented with strong documentation discipline
• Ability to travel to suppliers (domestic/international)