Project Manager in R&d Department

Vor 7 Tagen

Genève, Schweiz Spineart GmbH Vollzeit

At Spineart, we are relentlessly driven by quality, innovation, and simplicity in the pursuit of improved patient outcomes. By simplifying surgical procedures, we empower our teams to focus on what truly matters: enhancing patient care. This dedication to excellence not only benefits patients but also creates a dynamic and fulfilling workplace for our employees. Consequently, our commitment to growth is not limited to the company’s success. We want our talents to pursue their personal and professional journey. We foster an environment that encourages learning, where curiosity is celebrated, and talent development is a priority. Discover your potential with us.

**Project Manager in R&D department**:
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

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