Purpose: The R&D Medical Device Project Manager oversees and coordinates the successful development, delivery and maintenance phases of our medical device.

Key Responsibilities:

Project coordination and communication

• Lead, motivate and coordinate Product, R&D and QARA teams for timely and efficient product development, from product definition to design transfer validation.

• Maintain detailed project plan with stakeholders, defining tactics, owners, derisking and execution milestones, deliverables, budget and resources.

• Monitor project progress with stakeholders: identify risks, define mitigation tactics, trigger actions, and escalate when necessary.

• Serve as the primary point of contact for project-related communication with stakeholders.

• Prepare and deliver project status reports, project metrics, presentations, and updates to senior management and stakeholders.

  Agile implementation

• Define and apply Agile-inspired methodology for stakeholder empowerment, team scalability, priority clarity, delivery transparency and adaptability/responsiveness to change.

  Compliance Management

• Ensure that stakeholders deliver accurate and up-to-date DHF and DMR, in compliance with regulatory standards and company policies.

• Collaborate with QA and Regulatory Affairs to ensure regulatory and QMS adherence.

• Support regulatory filing, audits and inspections.

Functional relations:

• Work with Product and QARA Teams, R&D Teams , Finance, and external stakeholders (subcontractors, suppliers).

• Report to Senior Management.

• MS in Engineering/Science, or a related field. 

• Minimum 10 years in the medical device industry, with a focus on project management. 

• Successful leadership in developing and delivering medical devices comprising mechatronics, HW, SW in new product and post-market phases. 

• Proven experience in Agile project management. 

• Strong understanding of regulatory requirements and QMS in the US and Europe: 

• QSR/QMS: 21 CFR Part 820, ISO 13485 

• Development cycles implementing ISO 14971 (Risk Management), IEC 62304 (Software Development Lifecycle), IEC 62366-1 (Usability Engineering),  

• IEC 60601-1 and IEC 60601-1-2 

• As a plus: Development cycles implementing IEC 60601-4-5 and IEC 81001-5-1 (cybersecurity), ISO 10993 (Biocompatibility), 17664 (Reprocessing), AAMI ST98 (cleaning) 

• Extensive hands-on experience with V-cycle phases, Design Control, DHF, and DMR management. 

• Excellent organizational, communication, and interpersonal skills. 

• Effective in a dynamic environment with internal and external stakeholders. 

• Proficient in English and French. 

• PMP certification or equivalent is a plus.