Head of Medical Device Development — 3D-Printed Orthopedics

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

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.