Experienced Npi Engineer

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

Experienced NPI Engineer focused on manufacturing and supplier readiness for new product introductions in the healthcare industry. Responsibilities include process development, supplier qualification, PFMEA, validation, and problem-solving using methodologies like 8D and DMAIC. Requires a Bachelor's degree in engineering and 3-5 years of relevant experience.

What you'd actually do

  1. Lead the development and optimization of manufacturing processes for internal and external components and assemblies.
  2. Own and develop PFMEA, process flows, validation strategies, and control plans.
  3. Conduct supplier capability assessments, readiness reviews, and drive corrective action plans where needed.
  4. Provide expert DFM/DFA/DFX guidance during design phases and influence engineering decisions through data-driven recommendations.
  5. Plan, execute, and document process validations (IQ/OQ/PQ), ensuring compliance and robust process performance.

Skills

Required

  • Bachelor’s degree in Mechanical, Industrial, Electrical, Biomedical, or related engineering field.
  • 3–5 years of experience in manufacturing, NPI, supplier engineering, or process engineering.
  • Strong understanding of manufacturing processes, quality systems, and design transfer principles.
  • Demonstrated ability to lead cross-functional activities and manage complex technical tasks.
  • Strong analytical, problem-solving, and data-driven decision-making skills.
  • Excellent communication, stakeholder management, and collaboration capabilities.

Nice to have

  • Experience in regulated industries (medical devices highly preferred).
  • Strong knowledge of DFX methodologies, PFMEA development, Six Sigma, and validation standards.
  • Proficiency with CAD tools, statistical analysis software (e.g., Minitab), and DOE methods.
  • Experience working with suppliers globally and managing external manufacturing readiness.
  • Lean manufacturing or Six Sigma certification (Green Belt or higher).
  • Analytical Reasoning
  • Computerized Equipment Skills
  • Emerging Technologies
  • Gemba Kaizen
  • Issue Escalation
  • Lean Supply Chain Management
  • Problem Solving
  • Process Control
  • Process Engineering
  • Process Oriented
  • Product Improvements
  • Science, Technology, Engineering, and Math (STEM) Application
  • Situational Awareness
  • Supply Planning
  • Technical Research
  • Technologically Savvy
  • Validation Testing

What the JD emphasized

  • regulated industries (medical devices highly preferred)
  • Strong understanding of manufacturing processes, quality systems, and design transfer principles.
  • Demonstrated ability to lead cross-functional activities and manage complex technical tasks.
  • Strong analytical, problem-solving, and data-driven decision-making skills.
  • Excellent communication, stakeholder management, and collaboration capabilities.