Medical Equipment R&D Manager (relocation to Mauritius)

Natec Medical specializes in the development and manufacturing of medical devices, particularly advanced catheters, within the biomedical and mechanical engineering domains.

• Master's degree in Biomedical Engineering, Mechanical Engineering, or related fields.
• At least 8 years of experience in a senior engineering role within the medical devices industry, especially in catheter manufacturing.
• Proven track record of managing and delivering high-impact projects from concept to market.
• Comprehensive knowledge of ISO 13485, FDA, and MDR regulations.
• Demonstrated experience in leading cross-functional teams and mentoring technical staff.
• Ability to relocate to Mauritius.

Strategic Product Development:

• Lead the development of advanced catheters and related medical devices from concept to commercialization.
• Define and oversee the product development strategy, aligning with organizational objectives and market demands.
• Act as the chief technical expert for product innovations, ensuring optimal design and functionality.

Technical Innovation and Expertise:

• Drive innovation by integrating cutting-edge technologies and methodologies into product designs.
• Conduct advanced material selection, product testing, and validation activities to meet client and regulatory requirements.
• Lead design reviews, failure mode analysis, and risk assessments for ongoing and new projects.

Cross-Functional Collaboration:

• Liaise between R&D, Quality, Regulatory, Manufacturing, and Commercial teams to ensure cohesive project execution.
• Represent the R&D department in high-level meetings, contributing to organizational strategy and decision-making.
• Collaborate with clients and external stakeholders to translate market needs into innovative product solutions.

Compliance and Quality Assurance:

• Ensure all development activities comply with ISO 13485, FDA, MDR, and other regulatory standards.
• Partner with quality and regulatory teams to secure necessary certifications and approvals.
• Implement robust documentation practices and technical files compliance.

Project and Resource Management:

• Lead multiple complex R&D projects simultaneously, managing timelines, budgets, and resources.
• Manage project budgets in alignment with financial targets.
• Identify and mitigate risks proactively to ensure successful outcomes.

This position requires relocation to Mauritius.