Medical Device Development Manager

Team Leadership and Capability 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.

Product Development Leadership

• 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.

Design Controls and Process Excellence

• 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.

Cross-Functional and Office Collaboration

• 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.

Hands-On Technical Contribution

• 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.

Your Profile

Education

• 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.

Experience

• 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.