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.

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 Responsibilities

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.