Industrialization Engineer

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

About Sunrise Group

Sunrise Group is building the future of sleep health by combining breakthrough technology with expert care. We started in 2015 with a straightforward idea: sleep diagnosis should happen in the comfort of your own home, not in a hospital. To make that possible, we created a first-of-its-kind chin sensor, carefully validated through clinical research, reviewed by leading sleep experts, and cleared by the FDA.

About Sunrise Group

Sunrise Group is building the future of sleep health by combining breakthrough technology with expert care. We started in 2015 with a straightforward idea: sleep diagnosis should happen in the comfort of your own home, not in a hospital. To make that possible, we created a first-of-its-kind chin sensor, carefully validated through clinical research, reviewed by leading sleep experts, and cleared by the FDA.

Your Opportunity

You’ll join the Medical Devices team, which takes our diagnostic and treatment devices from R&D to series production. You’ll work daily with production, supply chain, and quality. Your mission: make R&D products manufacturable, testable, and economically viable, then run them through their first controlled series and hand them over to production. After that, you stay the technical go‑to person for product and process issues during the run.

Design for manufacturing

• Bring manufacturing, assembly, testability, and cost constraints into early design phases, and challenge design choices on their industrial impact.
• Own design-to-cost: estimate target unit cost (in-house assembly + purchased sub-assemblies) and propose savings before design freeze.

Industrialization

• Lead the industrialization of new products and product changes: assembly processes and workstations, routings, tooling, fixtures, target 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.

Pilot runs and transfer to production

• Plan and run pilot and first series, tracking yields and analyzing defects. Define phase-exit and transfer criteria.
• Train operators and formally hand each product over to the Production Manager.

Production support

• Be production’s technical point of contact for recurring issues, yield drift, and process or design changes.
• Provide cycle-time and yield data for capacity decisions, and drive continuous improvement and cost reduction.

Suppliers and industrial partners

• Write technical specifications for PCBAs, sub-assemblies, specific components, and test equipment.
• Act as technical point of contact for our EMS, mechanical, and packaging partners: design reviews, supplier DFM, quality issues, qualification (first articles, transfers, critical components, obsolescence).

Quality and regulatory

• Create the manufacturing documentation for new products (routings, work instructions, control plans, DMR elements) within our ISO 13485 quality system.
• Lead process and test equipment validation (IQ/OQ/PQ), and contribute to EU MDR, FDA, and UK MDR technical files and notified-body audits.
• Take part in root-cause analyses and CAPAs, and handle design changes that affect manufacturing.

What You Bring

• A master’s degree in engineering (civil or industrial engineering) or equivalent. 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: process validation, 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.

What Makes You Stand Out

• Experience in a regulated environment, ideally medical devices (ISO 13485, EU MDR, FDA)
• Assembly of miniaturized electronics or wearables
• Work with electronics manufacturing services (EMS) providers
• Several product launches run in parallel
• Hands‑on analysis of test and production data

About Our Team

At Sunrise, we’re tackling real sleep health challenges that affect millions. We keep things clear and simple , value trust and collaboration , and lead with optimism and compassion . These are the values that guide everything we do. If you’re looking for the freedom to take ownership of your work, make an impact, and be part of a team where you can bring your ideas to life, Sunrise might just be the right fit. Dreem Health / Sunrise is an Equal Opportunity Employer. We welcome people of all backgrounds and are committed to building a workplace where everyone feels included and respected. We do not tolerate discrimination or harassment of any kind.