Senior Device Development & Process Engineer

Summary:

Join the team of our client to drive the development and continuous improvement of standard craniomaxillofacial (CMF) medical devices. This position focuses on standard (non-personalized) devices and excludes R&D on 3D-printed patient-specific solutions. You will take a lead role in design, technical documentation, process optimization, and cross-functional collaboration, all within a regulated medical environment.

Key Responsibilities:

• Collaborate with surgeons to gather clinical needs and translate them into technical requirements
• Design and improve medical devices, create and manage design documentation (DHF, technical files)
• Plan and execute verification/validation and design transfer
• Optimize and validate manufacturing processes (milling, laser cutting, anodization, etc.)
• Lead technical communication with suppliers and internal stakeholders
• Improve design control processes and contribute to regulatory compliance (MDR, ISO 13485)

Requirements:

• Strong experience in standard product design (CAD, technical drawings, simulations)
• Background in manufacturing processes (e.g., turning, forging, laser cutting)
• Solid understanding of Design Control and Quality Systems in a medical context
• Excellent communication in English (written & spoken)
• Autonomous, organized, and able to lead technical initiatives
• Experience with risk management tools (e.g., FMEA)
• Familiarity with Agile is a plus