Senior Npi Engineer- Electrical

Johnson & Johnson Johnson & Johnson · Pharma · Danvers, MA +1

Senior NPI Engineer-Electrical role focused on the manufacturing engineering and process development for new electrical components and systems in the medical device industry. Responsibilities include collaborating with design teams, defining manufacturing processes and test strategies, partnering with suppliers for qualification, and supporting product validation.

What you'd actually do

  1. Serve as the primary technical contact and manufacturing engineering liaison between internal product development teams and external suppliers/contract manufacturers.
  2. Collaborate with design teams to provide DfX (manufacturing, test, assembly) feedback for PCBAs, HMI consoles, wiring harnesses, motors, batteries, and system-level designs.
  3. Define and develop manufacturing assembly processes and test strategies/requirements for new system product electrical sub-assemblies
  4. Partner with external manufacturing partners/supplier to develop and qualify test systems and execute TMVs
  5. Partner with R&D and suppliers to conduct risk assessments (FMEAs) and create process validation and qualification plans (MVP, IQ/OQ/PQ) for supplier execution.

Skills

Required

  • Bachelors degree in electrical engineering or related fields
  • 5+ years of experience as an NPI electrical design/test engineer
  • Demonstrated experience in printed circuit board manufacturing, SMT process, electrical component and assembly
  • Proficiency in Altium or similar CAD tools for schematic capture and PCB design
  • Demonstrated experience developing process validation plans, including IQ/OQ/PQ protocols/reports
  • Knowledge of FDA 21CFR820/821 and ISO 13485 requirements
  • Strong leadership, cross-functional communication, and proactive problem-solving

Nice to have

  • masters degree preferred
  • background in robotics, automotive, or medical devices manufacturing
  • Working knowledge of test systems- hardware and software development using LabVIEW, Python, C/C#, firmware and diagnostics for board level testing
  • Experience designing and executing Gauge R&R studies
  • Working with suppliers and EMS/CM partners highly preferred
  • Working knowledge of SAP a plus

What the JD emphasized

  • process validation and qualification plans (MVP, IQ/OQ/PQ)
  • FDA 21CFR820/821 and ISO 13485 requirements