Manufacturing & NPI Engineer – Medical Device

About the role

We are seeking a proactive Manufacturing & New Product Introduction (NPI) Engineer to support the production of our three existing medical‑device products and to lead the design transfer of two new projects with our contract manufacturers. You will act as the main liaison between our R&D team, product managers, and external partners, ensuring smooth scale‑up from prototype to full‑scale manufacturing.

Key responsibilities

• Manage ongoing manufacturing projects with contract manufacturers and suppliers to meet production demand.
• Engage hands‑on with key suppliers to improve processes, resolve issues and reduce costs, both remotely and on‑site.
• Collaborate with R&D and product managers to define product specifications, testing and acceptance criteria.
• Transfer and develop new production processes in close partnership with contract manufacturers.
• Support contract manufacturers in establishing the Device Master Record (drawings, assembly instructions, process validation, QC procedures, etc.).
• Maintain supplier documentation, evaluate and qualify new and existing suppliers, and follow ISO 13485 SOPs.

Required profile

• Degree (BSc or MSc) in mechanical, electrical, micro‑engineering, life sciences or related field.
• Minimum 3 years experience in medical‑device manufacturing, preferably in a startup or contract‑manufacturing environment.
• Broad knowledge of manufacturing and prototyping processes such as milling, turning, additive manufacturing, welding, joining, injection molding, silicone casting and chemical mixing.
• Understanding of process development, validation and statistical quality tools (six‑sigma, gauge R&R).
• Strong problem‑solving attitude, clear communication and ability to work within a matrix organization.

Required skills

• Milling
• Turning
• Additive Manufacturing
• Welding
• Joining
• Injection Molding
• Silicone Casting
• Chemical Mixing
• Process Validation
• Six Sigma
• Gauge R&R
• ISO 13485 Quality Management