Research And Development Engineer

Discover International; Île-de-France; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Discover International is supporting an established medical device organisation in the search for a Senior R&D Project Manager to lead the development of catheter-based medical devices from concept through to commercialization.

This senior technical and leadership role requires deep catheter development/manufacturing expertise and ownership of complex R&D programs across cross-functional teams, with a strong focus on quality and regulatory compliance.

Qualifications

• Master's degree in Biomedical or Mechanical Engineering.
• 5+ years' experience in medical device engineering/R&D.
• Experience moving devices from concept to commercialization.
• Strong knowledge of ISO 13485, FDA requirements and EU MDR.
• Experience leading complex, cross-functional R&D projects.
• Strong understanding of design controls, risk management, verification and validation.
• Mentoring and leading technical teams.

Responsabilités

• Lead catheter and medical device development from concept to commercialization.
• Own complex R&D projects across timelines, budgets, resources and deliverables.
• Drive design, material selection, prototyping, testing and validation.
• Lead design reviews, FMEA, risk assessments and problem-solving.
• Introduce new technologies, materials and manufacturing methodologies.
• Translate customer and market requirements into technically viable products.
• Partner with Quality and Regulatory on ISO 13485, FDA and EU MDR compliance.
• Ensure robust design documentation, technical files and development records.
• Lead cross-functional technical teams and mentor engineers.
• Identify technical and project risks and drive mitigation strategies.

Connaissances

Project leadership

Risk management

Design reviews

Cross-functional leadership

Mentoring engineers

Design controls

Regulatory understanding

Formation

Master's degree in Biomedical Engineering

Master's degree in Mechanical Engineering

Description du poste

We are supporting an established medical device organisation in the search for a Senior R&D Project Manager to lead the development of advanced catheter-based medical devices from concept through to commercialization.

This is a senior technical and leadership position for someone with deep catheter development/manufacturing expertise who wants to take ownership of complex R&D programs and help drive new product innovation.

The Role

You will act as a key technical and project authority within R&D, leading multiple medical device development programs while working closely with Quality, Regulatory, Manufacturing and Commercial teams.

Key responsibilities include:

• Lead catheter and medical device development from concept to commercialization
• Own complex R&D projects across timelines, budgets, resources and technical deliverables
• Drive design, material selection, prototyping, testing and validation activities
• Lead design reviews, FMEA, risk assessments and technical problem-solving
• Introduce new technologies, materials and manufacturing methodologies
• Translate customer and market requirements into technically viable products
• Partner with Quality and Regulatory teams on ISO 13485, FDA and EU MDR compliance
• Ensure robust design documentation, technical files and development records
• Lead cross-functional technical teams and mentor engineers
• Identify technical and project risks and drive mitigation strategies

Requirements

• Master's degree in Biomedical Engineering, Mechanical Engineering or a related discipline
• 5+ years' experience within medical device engineering/R&D
• Proven experience taking medical devices from concept through development and commercialization
• Strong knowledge of ISO 13485, FDA requirements and EU MDR
• Experience leading complex, cross-functional R&D projects
• Strong understanding of design controls, risk management, verification and validation
• Demonstrated experience mentoring and leading technical teams