Device development engineer

We are a Belgian engineering consulting firm that assists SMEs and large industrial organizations in bringing their innovation and R&D initiatives to life.

Job Description :

As a senior engineer, you'll lead the design and development of medical devices, balancing technical depth with strategic impact. You'll work independently, guide cross-functional teams, and ensure alignment with business goals. Key Responsibilities : Engage with surgeons to gather clinical input and translate user needs into technical requirements Design new devices and improve existing ones, including technical drawings and specifications Lead verification, validation, and documentation (DHF, Technical File) Ensure compliance with QMS and support design transfer to manufacturing and regulatory teams Drive process development : from manufacturing methods (e.g. milling, laser cutting) to quality inspection and post-processing Collaborate with subcontractors and manage technical communication Identify and implement process improvements and validations for new product introductions

Profile / Requirements :

Product Design Expertise : Strong skills in functional dimensioning, CAD, technical drawings, and numerical simulation tools Experience with standard production processes (e.g., milling, forging, laser cutting) Ideally familiar with medical bone screws, plates, and instruments Professional Experience : Proven background in product design and development with a strong technical focus Hands-on experience with Design History Files (DHF) and technical documentation Regulatory & Quality Knowledge : Solid understanding of Medical Device Regulation (MDR) and ISO 13485 Experience with risk management tools (e.g., FMEA, Hazard Analysis) Ability to ensure compliance independently throughout development activities Communication & Collaboration : Fluent in English (spoken and written), especially for technical documentation and presentations Comfortable communicating with internal teams, partners, surgeons, and subcontractors Able to adapt communication style to technical and non-technical audiences Leadership & Mentoring : Capable of leading technical discussions and mentoring junior team members or interns Skilled in coordinating cross-functional teams to align on project goals and timelines Work Ethic & Mindset : Rigorous, organized, and structured approach to work Able to work independently with minimal supervision Strong critical thinking and decision-making skills Proactive in identifying and solving complex technical challenges Additional Assets : Familiarity with Agile methodology is a plus Experience setting up and validating new processes for product industrialization