Program Manager M/F
Permanent Contract (CDI)
- Education: MS in Engineering/Science or equivalent
- Experience: 8+ years of experience in medical device product development.
- Desired experiences: Experience developing software-controlled medical electrical equipment.
Program Manager M/F
The Program Manager is directly responsible for the successful delivery of Quantum Surgical product development projects. He/she will handle the planning, coordination and leadership of the Engineering development activities throughout the product development lifecycle. The position includes establishing and driving project schedules, requirements, budgets, reviews, issue escalation, and responsibility for project deliverables following good design control practices.
The candidate should have demonstrated experience with early-stage product development and managing complex innovation programs requiring input from multiple engineering disciplines.
- Lead, plan, and coordinate product development activities throughout the lifecycle, from user needs definition to industrialization and validation.
- Create and maintain detailed project plans with work breakdown, deliverables, milestones, resources, and responsibilities.
- Lead, motivate and provide day-to-day direction to the project team to ensure on time delivery.
- Organize and lead weekly project meetings to track progress, manage risk and anticipate any impact on the plan.
- Provide timely and accurate information to management.
- Work with Marketing to establish the product scope.
- Work with Software, Hardware and System teams to identify and anticipate the main technical risks, establish the product requirements, and deliver quality products on time.
- Work with Risk and Usability engineers to ensure the proper implementation of risk management & usability engineering activities.
- Work with Cybersecurity experts to ensure the proper implementation of cybersecurity device design, labeling and documentation.
- Support Clinical in conducting pre-clinical and clinical studies.
- Support the Design transfer & Manufacturing teams in establishing the device DMR.
- Support the Regulatory Affairs team in establishing the regulatory filings (CE, 510k, etc.)
- Create and maintain an accurate design history file (DHF)
- Follow all applicable regulatory standards and quality procedures
- You have a MS in Engineering/Science or equivalent.
- You have 8+ years of experience in medical device product development.
- You have 5+ years of experience as program manager leading cross-functional teams.
- You are familiar with design controls in a CE/FDA regulated environment.
- You can communicate effectively and build relationships with internal/external stakeholders.
- You have an experience developing software-controlled medical electrical equipment.
- You have an experience with Agile software development methodology.
- You have excellent organization and communication skills.
- You are a strong team player.
Working at Quantum Surgical means:
- Joining a talented, dynamic and multicultural team whilst being part of the technological and human adventure for a company in full evolution.
- Sharing our culture of innovation, team spirit and result-oriented
- Taking up technical challenges
- Benefiting from a competitive compensation (fixed salary+ variable, BSPCE)
Diversity is one of our strong beliefs. We therefore carefully study every application without any consideration that could be related to either physical or moral characteristics.
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