Project Manager

    Spineart is a privately held medical device company focused on simplifying the surgical act by designing, developing and promoting safe and efficient solutions to spine surgeons, operating room teams, and patients.

    Spineart is a pioneer in its field, having introduced unique patented and clinically validated technologies in the fields of Minimally Invasive Surgery, Motion Preservation, Fusion, Biologics, and Fractures Treatment.

    For our R&D Department, we are looking for a

    PROJECT MANAGER

     

    Mission

    • Contribute to the design & development of new products
    • Coordinate simultaneously several projects
    • Interact with the Organization (MKT, OPS, RA/QA) at the different stages of the projects from design inputs to Product Launch
    • Contribute to the maintenance of existing product ranges
    • Comply with applicable regulatory requirements ISO 13485, 21CFR Part 820 and MDR 2017/745 (EU)
    • Establish and validate the design inputs
    • Supervise the design & drawings of new products according to the design specifications, costs objectives, performance and quality standards
    • Create and monitor the project planning
    • Check the engineering drawings
    • Responsible for prototyping and manufacturing of test devices in conjunction with internal & external manufacturers
    • Establish the test plan, execute or monitor the tests
    • Contribute to the design transfer of new products
    • Write the documentation, conduct Risk Analysis and Design Verification/Validation Master Plan, in accordance with Regulatory and Quality requirements
    • Build and maintain the Design History File (DHF) relative to the project
    • Additional activities

    –   Support to Regulatory Affairs and Product Quality (including Non-Conformity  analysis),

    –    Support to Operations, Process Validation Support and Marketing

     

    Profile

    • Mechanical Engineering degree or equivalent
    • 3/5 years min. as R&D Project Manager
    • Experience required in Medical devices for Spine, or Orthopedic, or any other medical device industries
    • Written and oral fluency in French and English
    • Very good writing and communication skills
    • Ability to use SolidWorks is a plus
    • Computer skills (Word, Excel, PowerPoint, Teams, etc…)
    • Ability to manage multiple responsibilities and tasks simultaneously, and to work autonomously
    • Solution oriented
    • Team player
    • Ability to meet deadlines, to prioritize work and to be strategic