MedTech Industrialization Lead

Sunrise; Namen; On-site; EUR 70,000 - 100,000; Full time

Job summary

Sunrise is seeking an experienced Industrialization/NPI engineer to bring next-gen medical devices from R&D to production. You will design for manufacturing, define processes, optimize costs, and lead pilot runs and first articles in collaboration with production, supply chain, and QA.

On-site role at least three days weekly; fluent in French and English; master’s degree in engineering and 5+ years in medtech or electronics, with a track record of moving a product from prototype to series.

Qualifications

• Master’s degree in engineering; experience matters more than the diploma.
• 5+ years in industrialization / NPI, in medtech, electronics, or a comparable industry.
• At least one product taken all the way from prototype to series production: DFM, process definition, pilot runs, transfer to production.
• Strong command of industrialization and quality tools: PFMEA, control plans, structured problem-solving.
• Experience designing or specifying end-of-line test equipment for electronic products.
• Ability to write technical specifications and manage suppliers on technical matters.
• Comfort at the interface between design and production: you can challenge R&D and earn the trust of the shop floor.
• Autonomy and pragmatism: you enjoy building what doesn’t exist yet.
• Fluent French and English.
• This is a hands‑on role: you’ll be on site at least 3 days a week.

Responsibilities

• Design for manufacturing: bring manufacturing, assembly, testability, and cost constraints into early design phases.
• Own design-to-cost: estimate target unit cost and propose savings before design freeze.
• Lead the industrialization of new products and product changes: assembly processes, routings, tooling, fixtures, and cycle times.
• Define in-process controls and end-of-line test equipment with R&D, from specification through development or sourcing to validation.
• Manage version transitions with production and supply chain.
• Plan and run pilot and first series, tracking yields and defects; define transfer criteria.
• Train operators and formally hand each product over to Production.
• Be production’s technical point of contact for recurring issues, yield drift, and process changes.
• Provide cycle-time and yield data for capacity decisions; drive continuous improvement and cost reduction.
• Write technical specs and manage EMS, mechanical, and packaging partners: design reviews, DFM, QA issues, qualification.
• Lead validation activities (IQ/OQ/PQ) and contribute to regulatory files and audits.

Skills

Industrialization

NPI

Process validation

PFMEA

Control plans

Supplier management

End-of-line test design

Technical specifications

On-site collaboration

Autonomy

Education

Master's in Engineering

Tools

ISO 13485 knowledge

Design for manufacturing tooling

EMS coordination

Job description

Sunrise is seeking an experienced Industrialization/NPI engineer to bring next-gen medical devices from R&D to production. You will design for manufacturing, define processes, optimize costs, and lead pilot runs and first articles in collaboration with production, supply chain, and QA.

On-site role at least three days weekly; fluent in French and English; master’s degree in engineering and 5+ years in medtech or electronics, with a track record of moving a product from prototype to series.