We are looking for a Project Manager
As a member of the Research and Development Team you will lead the design and development of surgical instruments and implants medical device in Spine.
Day to day, you will work with a cross-functional product team consisting of product development engineer, project engineer, marketing product manager, industrialization engineer, regulatory and QA engineer.
Your main responsibilities will be:
- Lead product development activities
- Build along with regulatory department the regulatory strategy to access US (PMA) & European markets (CE mark)
- Coordinate simultaneously several projects
- Comply with applicable regulatory requirements ISO 13485, 21CFR Part 820 and MDR 2017/745 (EU)
- Interact with the Organization (MKT, OPS, RA/QA) at the different stages of the projects from design inputs to Product Launch
- Contribute to the design & development of new products and to the maintenance of existing product ranges
- Establish and validate the design inputs
- Supervise the design & drawings of new products according to the design specifications, costs objectives, performance and quality standards
- 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
Who you are:
- Mechanical Engineering degree or equivalent with experience of 8/10 years in R&D in medical devices
- Successful experiences as R&D Project Manager
- Experience required in Medical devices for Spine, or Orthopedic
- Ability to manage multiple responsibilities and tasks simultaneously, and to work autonomously
- Ability to meet deadlines, to prioritize work and to be strategic
- Inventive, curious, rigorous, meticulous, able to propose innovative and efficient technical solutions
- Interpersonal skills and enjoy working in a team
- Very good writing and communication skills
- Fluent in English (written and spoken, recent professional practice)
- Computer skills (Word, Excel, PowerPoint, Teams, etc…)
- Ability to use Solidworks a plus
If you think you are a good match for this role, apply today here
We look forward to receiving your application.