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Job Function:

Supply Chain Engineering:

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Aachen, North Rhine-Westphalia, Germany

Job Description:

Senior NPI Engineer (Supplier & Process Engineering) (m/f/d)

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.

Required Skills:

Preferred Skills:

Agile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection