Job Summary

The Senior NPI Engineer leads supplier and process engineering activities for new product introductions. This role drives robust industrialization, ensures supplier readiness, and owns process validation and risk management activities. The Senior NPI Engineer influences design decisions, leads cross‑functional alignment, and ensures flawless design transfer and launch readiness.

Key Responsibilities

• Lead process development and industrialization for internal and external manufacturing processes.

• Own PFMEA, control plans, validation strategies, capability studies, and documentation.

• Conduct supplier capability assessments, gap analysis, and readiness reviews.

• Provide authoritative DFM/DFA/DFX guidance to R&D and program teams.

• Lead process validations (IQ/OQ/PQ), data analysis, and technical decision-making.

• Drive PPAP deliverables, supplier qualification, and tooling readiness.

• Partner with R&D, Regulatory, Operations, and Quality to ensure seamless design transfer.

• Identify risks, define mitigation actions, and ensure compliance with FDA, ISO 13485, and internal quality systems.

• Lead structured problem-solving (DMAIC, 8D, root cause analysis) for supplier or process failures.

• Support cost, yield, and scalability improvements throughout the NPI lifecycle.

• Represent the function in program leadership meetings and provide readiness updates to management.

Qualifications – Required

• Bachelor’s degree in Mechanical, Industrial, Electrical, Biomedical, or related engineering field.

• 7–10+ years of experience in NPI, Supplier Engineering, Manufacturing Engineering, or Process Engineering.

• Demonstrated expertise in DFX, PFMEA, process validation, and supplier qualification.

• Strong experience in regulated environments (medical device strongly preferred).

• Proven ability to lead cross-functional initiatives and influence technical decisions.

• Strong data analysis and statistical skills (DOE, MSA, SPC).

Qualifications – Preferred

• Experience with PPAP/APQP and complex supplier ecosystems.

• Background in micro‑assembly, catheter manufacturing, machining, electronics, or automated processes.

• Six Sigma Green Belt or Black Belt certification.

• Experience mentoring junior engineers.

Key Competencies

• Technical authority & decision-making

• Influence & cross-functional leadership

• Advanced problem-solving

• Execution rigor & ownership

• Risk management & quality compliance

• Strategic thinking & scalability mindset

The anticipated base pay range for this position is 75.000 EUR to 118.450 EUR.

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, and programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Required Skills:

Preferred Skills: