> Markdown version of [/jobs/ext/1996968-medical-device-development-manager](https://www.wearedevelopers.com/jobs/ext/1996968-medical-device-development-manager). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Medical Device Development Manager - **Company:** MAT BEL Materialise NV - **Location:** Leuven, Belgium - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** 3D Printing, Verification and Validation (Software) - **Published:** August 9, 2026 - **Apply:** https://www.adzuna.be/details/5833562992 ## About the Role * Master's degree or PhD in Biomedical Engineering, Mechanical Engineering, Materials Engineering, or a related engineering discipline. * Equivalent combination of education and relevant experience may be considered. * 5 to 10 years experience in medical device development, preferably in orthopedic or CMF devices, implants, surgical instruments, or patient-specific solutions. * Demonstrated experience in leading engineering teams or technical groups in a regulated environment. * Strong working knowledge of medical device design controls and product development processes. * Experience with personalized devices, additive manufacturing / 3D printing, and/or orthopedic applications is highly preferred. * Proven track record of successfully bringing products through development to transfer or commercialization. * Experience working in cross-functional environments involving quality, regulatory, manufacturing, and clinical stakeholders. ## Description The Device Development Manager is responsible for leading a team of development engineers in the design, development, and lifecycle support of personalized and standard medical devices, including 3D-printed surgical guides and implants. This role combines technical leadership, people management, and operational excellence in product development., * Lead, coach, and develop a team of device development engineers working on personalized and standard medical devices. * Set clear OKRs (Objectives and Key Results) for each team member and follow up in periodical check-ins. * Build and maintain a high-performing engineering team with the appropriate technical skills, regulatory awareness, and problem-solving capabilities. * Identify competency gaps and define training, mentoring, and development plans to ensure team readiness for current and future business needs. * Foster a culture of ownership, collaboration, innovation, quality, and continuous improvement. * Support resource planning, workload balancing, and prioritization across projects and product lines. * Recruit, onboard, and retain strong engineering talent aligned with company values and strategic needs. * Lead and contribute to the development of standard and personalized 3D-printed guides and implants for various applications. * Translate clinical, business, and technical requirements into robust product development plans and engineering deliverables. * Drive product development activities across the full design and development lifecycle, including: user needs and design inputs, concept development, risk management, design outputs, verification and validation, design reviews, design transfer, change management * Collaborate closely with clinical, regulatory, quality, manufacturing, and commercial stakeholders to ensure successful product development and launch. * Ensure products are safe, effective, manufacturable, scalable, and aligned with customer and patient needs. * Ensure design control processes are implemented effectively and efficiently across development activities. * Drive compliance with applicable regulations and standards, such as FDA 21 CFR 820, ISO 13485, ISO 14971, MDR, and other relevant guidance for medical device development. * Continuously improve development processes, templates, governance, and documentation practices to enhance both compliance and development speed. * Promote pragmatic, right-sized process implementation that balances innovation, compliance, and operational efficiency. * Partner with Quality Assurance, Regulatory Affairs, Manufacturing Engineering, Clinical/Medical teams, Supply Chain, and Business Line management to ensure smooth execution of development programs. * Act as a technical and organizational interface between R&D and other departments. * Align within the community of practice with other R&D teams in Paris and Rio Claro (Brazil). * Communicate progress, risks, trade-offs, and resource needs clearly to management and stakeholders. * Contribute to portfolio planning, technical roadmap discussions, and strategic decisions for orthopedic product lines. * Serve as an active technical contributor on selected orthopedic development projects. * Provide technical guidance in device design, materials selection, mechanical performance, patient-specific design considerations, and additive manufacturing processes. * Review and contribute to engineering documentation, design reviews, technical justifications, and problem-solving activities. * Support root cause investigations, design changes, and continuous product improvements across the product lifecycle. ## Related Videos - [Times of (climate) crisis - How and why sustainable software is a must!](https://www.wearedevelopers.com/videos/988-times-of-climate-crisis-how-and-why-sustainable-software-is-a-must) - [How I built my own intelligent Robot Arm from Scratch](https://www.wearedevelopers.com/videos/100097-how-i-built-my-own-intelligent-robot-arm-from-scratch) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Kettle and Pot or Peas in a Pod? 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