Principal Npi Engineer

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

Principal NPI Engineer at Johnson & Johnson focused on leading the industrialization of new product introduction (NPI) processes, supplier engineering, and process development within the healthcare domain. The role involves technical leadership, strategy development, supplier capability assessment, influencing product architecture, ensuring process validation and quality compliance with regulatory standards like FDA and ISO 13485, and coaching engineering teams. Requires a strong track record in regulated industries, particularly medical devices, with expertise in DFX, PFMEA, and validation strategies.

What you'd actually do

  1. Serve as the technical expert and decision-maker for supplier and process engineering strategy across major NPI programs.
  2. Act as a key technical leader in the process development and engineering space. Leading initiatives to support process and SOP improvement while upskilling existing team members, and supporting the implementation of a structured approach to process development.
  3. Lead efforts to optimize new and existing manufacturing processes through the application of scientific and data-driven methodologies, ensuring efficiency, scalability, and compliance with regulatory standards.
  4. Implement and promote the use of data analytics to drive decision-making processes, leveraging statistical methods and process monitoring tools.
  5. Establish best practices, process standards, and validation frameworks that elevate organizational capability.

Skills

Required

  • Bachelor’s degree in Mechanical, Industrial, Electrical, Biomedical, or related engineering discipline
  • 10–15+ years of experience in NPI, Supplier Engineering, Manufacturing Engineering, or Process Engineering
  • Proven track record leading NPI industrialization for complex electromechanical, micro‑assembly, or high‑reliability components in regulated industries (medical devices strongly preferred)
  • Deep expertise in DFX, advanced process development, PFMEA, validation strategies, and supplier technology readiness
  • Strong experience collaborating with global suppliers and leading high‑impact technical initiatives
  • Demonstrated ability to influence product architecture and cross-functional decision-making

Nice to have

  • Master’s degree
  • Experience with PPAP/APQP, high-complexity supplier ecosystems, or advanced automation
  • Six Sigma Black Belt or equivalent advanced statistical training
  • Experience in scaling technologies across global supply networks
  • History of coaching, mentoring, and elevating engineering capability at an organizational level

What the JD emphasized

  • regulated industries
  • FDA
  • ISO 13485
  • process validation
  • supplier engineering
  • NPI industrialization
  • complex electromechanical
  • micro-assembly
  • high-reliability components
  • medical devices