Medical Device Development Manager

Materialise; Heverlee; Sur place; EUR 90 000 - 140 000; Plein temps

Résumé du poste

Materialise Medical is seeking a Device Development Manager to lead a team of engineers in the design, development, and lifecycle support of personalized and standard medical devices, including 3D-printed guides and implants.

You will drive design controls, regulatory compliance, and cross-functional collaboration with QA, Regulatory, Manufacturing, and Clinical teams while contributing hands-on to orthopedic projects.

Qualifications

• 5–10 years of medical device development experience in regulated environments.
• Proven track record leading engineering teams or technical groups.
• Strong knowledge of medical device design controls and development processes.
• Experience with personalized devices, additive manufacturing/3D printing, or orthopedic applications.
• Experience collaborating with quality, regulatory, manufacturing, and clinical stakeholders.

Responsabilités

• Lead a team of device development engineers for personalized and standard medical devices.
• Translate requirements into robust development plans and deliverables across full design lifecycle.
• Ensure design control compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, MDR.
• Collaborate with QA, Regulatory, Manufacturing, Clinical, and Commercial teams to drive launches.
• Contribute hands-on technical work on orthopedic projects and post-market support.

Connaissances

Leadership

Regulatory awareness

Additive manufacturing

Cross-functional collaboration

Project management

Design reviews

Formation

Master’s or PhD in Biomedical/Mechanical/Materials Engineering

Outils

Regulatory standards

Description du poste

At Materialise Medical, we believe that better healthcare starts with solutions designed around the individual patient. If you’re passionate about bringing personalized care to every patient, you’ll love being a part of this team. Through the technology we develop, researchers, engineers, and clinicians are revolutionizing personalized treatment — helping improve and save lives daily.The Device Development M anager 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.The manager ensures that the development team possesses the required skills, capabilities, and development mindset to deliver innovative, compliant, and clinically relevant products. In parallel, this role is accountable for establishing, maintaining, and continuously improving effective and efficient design control processes in line with applicable medical device regulations and quality standards.In addition to leading the team, the Device Development manager remains personally engaged in product development activities , contributing directly to the development of orthopedic product lines from concept through design transfer and post-market support.Key Responsibilities1. Team Leadership and Capability DevelopmentLead, 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.2. Product Development LeadershipLead 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 managementCollaborate 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.3. Design Controls and Process ExcellenceEnsure 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.4. Cross-Functional and Office CollaborationPartner 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.5. Hands-On Technical ContributionServe 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.Your ProfileEducationMaster’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.Experience5 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.What’s waiting for youWork that mattersThe technology we build at Materialise pushes the boundaries. You’ll find pride in building something that matters, whether you designed it, printed it, or shipped it. No matter your role, we unlock new possibilities to build a better and healthier world every day.At Materialise, we expect you to think about the customer, not just the task. You push for better solutions and care about the difference your work makes.A people-centered spaceWhen you join Materialise, you join a group of colleagues invested in you, not just your work. From your own team to a department across the world, you’ll find a sense of belonging with people who help without being asked, challenge you, and have your back.At the same time, we expect you to invest in the people around you — not just your own work — to make the group stronger than the sum of its parts.An environment of trustAs a company of innovators, we know how crucial autonomy is in your work. When we hire you, we trust in your expertise, giving you space to organize your tasks, work flexibly, and make your own calls.At Materialise, we expect you to deliver on that trust and keep your commitments.A career ready to buildWhen you see opportunities for your career to grow at Materialise, we encourage you to go for them. People shape a fulfilling career at their own pace here.At Materialise, we expect you to take initiative in your own development. Don’t wait for someone else to plan your career. Step into the space and make it count.Make a difference together with the Medical team.