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 DescriptionAs 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 ResponsibilitiesEngage with surgeons to gather clinical input and translate user needs into technical requirementsDesign new devices and improve existing ones, including technical drawings and specificationsLead verification, validation, and documentation (DHF, Technical File)Ensure compliance with QMS and support design transfer to manufacturing and regulatory teamsDrive process development: from manufacturing methods (e.g. milling, laser cutting) to quality inspection and post-processingCollaborate with subcontractors and manage technical communicationIdentify and implement process improvements and validations for new product introductions📚 Profile / RequirementsProduct Design Expertise:Strong skills in functional dimensioning, CAD, technical drawings, and numerical simulation toolsExperience with standard production processes (e.g., milling, forging, laser cutting)Ideally familiar with medical bone screws, plates, and instrumentsProfessional ExperienceProven background in product design and development with a strong technical focusHands-on experience with Design History Files (DHF) and technical documentationRegulatory & Quality KnowledgeSolid understanding of Medical Device Regulation (MDR) and ISO 13485Experience with risk management tools (e.g., FMEA, Hazard Analysis)Ability to ensure compliance independently throughout development activitiesCommunication & CollaborationFluent in English (spoken and written), especially for technical documentation and presentationsComfortable communicating with internal teams, partners, surgeons, and subcontractorsAble to adapt communication style to technical and non-technical audiencesLeadership & MentoringCapable of leading technical discussions and mentoring junior team members or internsSkilled in coordinating cross-functional teams to align on project goals and timelinesWork Ethic & MindsetRigorous, organized, and structured approach to workAble to work independently with minimal supervisionStrong critical thinking and decision-making skillsProactive in identifying and solving complex technical challengesAdditional AssetsFamiliarity with Agile methodology is a plusExperience setting up and validating new processes for product industrialization🌟 Why join us ?We offer you a position as a consultant within the fascinating world of high tech and innovation. We provide a complete package with on one side training, coaching and a close follow-up, and on the other side a balanced salary package with fringe benefits based on your capabilities and experience.Working with us means choosing a long-term perspective, development possibilities, and a personal approach. A human-centered, diverse company that values and supports your physical and mental well-being.