Talent.com
NPI Process Development Engineer
NPI Process Development EngineerNatus Medical • Middleton, WI, United States
NPI Process Development Engineer

NPI Process Development Engineer

Natus Medical • Middleton, WI, United States
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

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

  • 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)
  • Pay Transparency Details : The actual base pay offered will vary depending on multiple factors including job-related knowledge / skills, experience, business needs, geographical location, and internal equity. At Natus, it is not typical for an individual to be hired at or near the top end of the range. The general range for this work group is between 110K-170K USD.

    Compensation and Benefits : Comprehensive benefit package that starts on your 1st day including health benefits, 401k contribution, 7 paid holidays + 2 floating holidays of your choosing, generous paid time off program, tuition reimbursement assistance program and more!

    Be the People part of the Neuro Solution. Apply Today.

    Note : We are unable to support visa sponsorships now or in the future for this role.

    EEO Statement : Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.

    #natus #LI-NR #INDNATUS #natuscareers #natusneuro #Wisconsinjobs #Engineering #Hybrid

    [job_alerts.create_a_job]

    NPI Process Development Engineer • Middleton, WI, United States

    [internal_linking.similar_jobs]
    Outpatient Pediatric need in Southern WI and Northern IL

    Outpatient Pediatric need in Southern WI and Northern IL

    HealthEcareers - Client • Monroe, WI, USA
    [job_card.full_time]
    SSM Health is an Equal Opportunity Employer : .Outpatient Clinic in Southern WI & Northern IL - Lucrative Sign on Bonus!. Outpatient Clinic; 4-5 day work week working in Monroe, WI and Freeport, IL.Jo...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Physical Therapist / PT

    Physical Therapist / PT

    Aegis Therapies • Monroe, WI, United States
    [job_card.full_time]
    Setting : Nursing Home, Rehabilitation Center, Skilled Nursing Facility.We invest in your future with specialized, ongoing training, career advancement opportunities and the strongest clinical suppo...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Family Practice / Primary Care Nurse Practitioner - Competitive Salary

    Family Practice / Primary Care Nurse Practitioner - Competitive Salary

    DocCafe • Middleton, Wisconsin, US
    [job_card.full_time]
    DocCafe has an immediate opening for the following position : Nurse Practitioner - Family Practice / Primary Care in Middleton, Wisconsin. DocCafe is the premier physician and advanced practice job boa...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Divisional Merchandising Manager

    Divisional Merchandising Manager

    Colony Brands, Inc. • Monroe, WI, US
    [job_card.full_time]
    We are seeking a Merchandising leader who knows the home goods business, is a positive leader, and brings an entrepreneurial spirit to identify, develop, and grow others and business opportunities....[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Registered Nurse (RN) - Full-Time / Part-Time Day / Evening

    Registered Nurse (RN) - Full-Time / Part-Time Day / Evening

    Wisconsin Dells Health Services • Baraboo, WI, United States
    [job_card.full_time] +1
    Registered Nurse (RN) - Starting wage up to $46.WisconsinDells Health Services is proud to be rated 5-Stars in Quality Measures by CMSand is considered a leading provider of skilled nursing and reh...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Physician (MD / DO) - Pediatrics - General / Other in Monroe, WI

    Physician (MD / DO) - Pediatrics - General / Other in Monroe, WI

    LocumJobsOnline • Monroe, WI, US
    [job_card.full_time] +1
    Doctor of Medicine | Pediatrics - General / Other.Competitive weekly pay (inquire for details) .LocumJobsOnline is working with CompHealth to find a qualified Pediatrics MD in Monroe, Wisconsin, 5356...[show_more]
    [last_updated.last_updated_30] • [promoted]
    General Manager(02080) - 6915 University Ave.

    General Manager(02080) - 6915 University Ave.

    Domino's Pizza • Middleton, WI, United States
    [job_card.full_time]
    Company Description Job Description ABOUT THE JOB You were born to be the boss.You get up in the morning and you make sure everyone else in the house is doing what they need to do.Then you go to...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Nurse Practitioner - Pain Management - $112K-157K per year

    Nurse Practitioner - Pain Management - $112K-157K per year

    UW Health • Prairie du Sac, WI, United States
    [job_card.full_time]
    UW Health is seeking a Nurse Practitioner Pain Management for a job in Prairie du Sac, Wisconsin.Job Description & Requirements. Monday- Friday, 8 hour shifts between 8 : 00 am to 5 : 00 pm.No weekends,...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Assembler I - Electronics Manufacturing - $1,500 Sign-On Bonus

    Assembler I - Electronics Manufacturing - $1,500 Sign-On Bonus

    Ultratec, Inc. • Verona, WI, United States
    [job_card.full_time]
    Madison, WI | Advanced Assembly, Inc.Madison's west side (University Research Park).Assembler I (entry-level) positions.Full benefits (medical, dental, vision, 401k, PTO).Advancement opportunities ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Pediatric Physician Job | SSM Health | Baraboo, Wisconsin (WI) | Teaching Option

    Pediatric Physician Job | SSM Health | Baraboo, Wisconsin (WI) | Teaching Option

    Jackson Physician Search • Baraboo, US
    [job_card.full_time] +1
    Clare Hospital in Baraboo, Wisconsin (WI) seeks an Pediatrician to join our collegial team.Mainly outpatient with a 4-day work week, tele-medicine, and part-time options available.Team focused on t...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Surgery - General Physician

    Surgery - General Physician

    SSM Health • Middleton, WI, USA
    [job_card.full_time]
    Surgery - General Physician at SSM Health summary : .SSM Health Dean Medical Group is seeking a full-time BE / BC Plastic Surgeon with expertise in Reconstructive Microsurgery, including DIEP and Free ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Family Practice Physician Is Needed for Temp to Perm Help in WI

    Family Practice Physician Is Needed for Temp to Perm Help in WI

    CompHealth • Baraboo, US
    [job_card.permanent] +1
    Though your CompHealth recruiter will be your single point of contact, they're backed by dozens of specialized teams, giving them the ability to focus on the details that matter to you.That means w...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Locum Physician (MD / DO) - Anesthesiology - General / Other in Monroe, WI

    Locum Physician (MD / DO) - Anesthesiology - General / Other in Monroe, WI

    LocumJobsOnline • Monroe, WI, US
    [job_card.full_time] +1
    Doctor of Medicine | Anesthesiology - General / Other.Competitive weekly pay (inquire for details) .LocumJobsOnline is working with VISTA Staffing to find a qualified Anesthesiology MD in Monroe, Wis...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Assistant Director, Engineering

    Assistant Director, Engineering

    Great Wolf Lodge • Baraboo, WI, US
    [job_card.full_time]
    Pay : $75000 per year - $85000 per year.Assistant Director of Engineering.A great place to start or advance your career with cross-training, scholarship fund, and talent development programs at all ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Exceptional ENT / Otolaryngology Physician Opportunity to Join a Leading-Edge Team

    Exceptional ENT / Otolaryngology Physician Opportunity to Join a Leading-Edge Team

    HealthEcareers - Client • Monroe, WI, USA
    [job_card.full_time]
    SSM Health is an Equal Opportunity Employer : .About SSM Health Monroe Hospital : .SSM Health Monroe Clinic is excited to announce an exceptional opportunity for a full-time Otolaryngologist to join ou...[show_more]
    [last_updated.last_updated_30] • [promoted]
    SERVICE TECHNICIAN

    SERVICE TECHNICIAN

    Central Ag Supply • Baraboo, WI, US
    [job_card.full_time]
    SERVICE / INSTALLATION TECHNICIAN.Juneau & Baraboo are now hiring additional Dairy Equipment, Refrigeration & Robotics Technicians. Ready to Work on Technology That Actually Matters? With a new expe...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    General Manager - 0636

    General Manager - 0636

    Five Guys • Middleton, WI, United States
    [job_card.full_time]
    The starting pay for this position is $55,000 / annually.This position is also eligible for participation in performance-based bonus rewards. What can you expect? • Real work / life hours of operation....[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Hiring Now - Work from Home - No Experience

    Hiring Now - Work from Home - No Experience

    OCPA • Monticello, Wisconsin, us
    [filters.remote]
    [job_card.part_time] +1
    Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies. We guarantee 15-25 hours per week with an hourly pay of bet...[show_more]
    [last_updated.last_updated_30] • [promoted]