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Natus Medical Incorporated · 2 weeks ago

NPI Process Development Engineer

Middleton, WI

Contract

Hybrid

Senior Level

$110K/yr - $170K/yr

5+ years exp

Natus Medical Incorporated has been delivering industry-leading neuro solutions for over 80 years. The NPI Process Development Engineer will bridge R&D design intent with compliant manufacturing processes for electromechanical medical devices, working closely with various teams to ensure a smooth transition from prototype to production.

BiotechnologyHealth CareHealth DiagnosticsMedical

No H1B

Responsibilities

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

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

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

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

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

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

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

Qualification

NPI Process DevelopmentDFM/DFA/DFTProcess Validation (IQ/OQ/PQ)FDA 21 CFR 820Supplier Technical ManagementElectro-mechanical AssembliesLean ManufacturingProblem-solvingCommunication SkillsDocumentation Discipline

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)

Benefits

Health benefits

401k contribution

7 paid holidays + 2 floating holidays of your choosing

Generous paid time off program

Tuition reimbursement assistance program

Company

Natus Medical Incorporated

Natus Medical Incorporated (Natus) offers medical equipment, software, supplies and services for the diagnosis, monitoring, and treatment of impairments and disorders effecting the brain, neural pathways, and eight sensory nervous systems.

Founded in 1987

Auckland, Auckland, NZL

1001-5000 employees