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We are searching for the best talent for Sr. NPI Engineer.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Senior NPI Engineer (Supplier & Process Engineering)

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. 

• Mentor & guide junior and experienced Engineers 

Qualifications – Required 

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

• 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). 

• Business Fluent English (& Business fluent german for openings in germany) 

Qualifications – Preferred 

• Experience with PPAP/APQP and complex supplier ecosystems. 

• Background in micro‑assembly, joining technologies, injection molding, catheter manufacturing, machining, electronics, or automated processes. 

• Lean manufacturing or Six Sigma certification (Green Belt or higher).

• Experience in mentoring junior engineers. 

• Proficiency with CAD tools, statistical analysis software (e.g., Minitab, JMP) 

• Basics of project management 

Key Competencies 

• Technical authority & decision-making 

• Influence & cross-functional leadership 

• Advanced problem-solving 

• Execution rigor & ownership 

• Risk management & quality compliance 

• Strategic thinking & scalability mindset 

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