What you’ll be doing:

• Execute design transfer activities from NPI through EVT/DVT, pilot builds, and ramp-up, ensuring designs are manufacturable, scalable, and production-ready.
• Develop and maintain design transfer documentation, including drawings, specifications, BOMs, and manufacturing requirements.
• Support production readiness reviews by identifying design-related risks and gaps prior to commercial release.
• Partner with Product Engineering to provide manufacturing-driven input into design decisions during development.
• Serve as a technical interface with Contract Manufacturers during design transfer and early production phases.
• Support early manufacturing data analysis during pilot and ramp-up phases to identify design-related risks and inform downstream process optimization.
• Participate in structured technical investigations during early production using root cause analysis methodologies (8D, 5 Why, FMEA).
• Provide technical input to Engineering Change Orders (ECOs) impacting manufacturing readiness and early production.
• Verify the effectiveness of design-related corrective actions during early production phases prior to handoff.

What you need to have:

• Bachelor’s or Master’s degree in Mechanical, Industrial, Biomedical Engineering, or a related field.
• 5+ years of experience in regulated manufacturing environments, with strong exposure to design transfer, industrialization, or manufacturing engineering.
• Proven hands-on experience supporting EVT/DVT builds, pilot runs, and production ramp-ups.
• Strong understanding of manufacturing processes, production systems, and quality controls.
• Solid experience applying root cause analysis tools (8D, 5 Why, FMEA) in manufacturing or industrialization contexts.
• Familiarity with medical device quality systems and change control processes (ISO 13485, FDA 21 CFR 820).
• Ability to work cross-functionally and influence technical decisions without direct authority.
• Strong technical documentation and communication skills.
• Experience with Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.
• Exposure to scaling products from pilot to high-volume manufacturing.
• Experience working directly with Contract Manufacturers and global supply chains.
• Familiarity with statistical tools (SPC, capability analysis) and basic data visualization.
• Experience in fast-paced, high-growth product development environments.

What we would love to see:

• Experience leveraging data, analytics, or automation tools to support manufacturing readiness, early risk detection, or investigation efficiency during design transfer and ramp-up phases.
• Knowledge of Lean or Six Sigma principles applied pragmatically to reduce manufacturing risk and improve first-pass success during industrialization.
• Demonstrated impact improving production readiness, yield, or ramp-up efficiency through better design-for-manufacturing decisions or early risk mitigation.
• Familiarity with applying analytics or structured data analysis to support design transfer decisions (e.g., yield trends, pilot build data, early production signals).
• Experience supporting scale-up from pilot to high-volume manufacturing, particularly during early ramp-up and stabilization.
• Background in medical device startups or high-growth product environments where speed, pragmatism, and execution quality are critical.
• Exposure to simulation, modeling, or digital tools used to assess manufacturability, production constraints, or design trade-offs (nice to have).

To ensure you feel good solving a big Human problem, we offer:

• A stimulating, fast-paced environment with lots of room for creativity.
• A bright future at a promising high-tech startup company.
• Career development and growth, with a competitive salary.
• The opportunity to work with a talented team and to add real value to an innovative solution with the potential to change the future of healthcare.
• A flexible environment where you can control your hours (remotely) with unlimited vacation.
• Access to our health and well-being program (digital therapist sessions).
• Remote or Hybrid work policy.
• To get to know more about our Tech Stack, check here.

42000 - 66000 EUR a year