Project Manager

For our R&D department in Spineart headquarter, we are currently recruiting 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 and the integration of new product ranges
  • Comply with applicable regulatory requirements ISO 13485, 21CFR Part 820, MDD 93/42/EEC 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), as well as 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
  • Expertise in the risk analysis, elaboration of VMP and Engineering Analysis
  • Goold knowledge of the quality standards ISO 13485, 21 CFR part 820, CE 93/42/ECC and 2017/745
  • 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