Project Manager

vor 5 Monaten

PlanlesOuates, Schweiz Spineart SA Vollzeit

We are looking for a **Project Manager**.

As a member of the **Research and Development **Team you will play an integral part in helping Spineart drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

You will lead the design and development of surgical instruments and implants medical devices used in **Spine Arthroplasty**.

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 arthroplasty 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, or any other medical device industries
- 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 )

A plus:

- Experience in Arthroplasty is a significant plus
- Ability to use SolidWorks
-------------------------------------------------------------------------------
- **Who we are**

Our success also depends on our team’s value. The human being is at the centre of our concerns. We pay special attention to our recruitment to make Spineart a great place to work.

For us, soft skills are as important as hard skills. What we expect from our employees is nothing short of real team spirit, mutual assistance, and self-transcendence.

Our philosophy: Quality, Innovation, Simplicity

Our values: Respect, Integrity, Solution oriented

**Things you will enjoy**
- Modern infrastructure
- Sports activities during lunch break
- Team events
- Direct cooperation with all departments
- Young, motivated team
- Agile and international environment
- Full time position
- Home office: 1 day per week
- Good Social insurances package

**Job Types**: 100%, Permanent

Schedule:

- Monday to Friday

Ability to commute/relocate:

- 1228 Plan-les-Ouates, GE: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- Project management: 8 years (required)
- Medical devices: 8 years (preferred)

**Language**:

- Fluent French and English (required)

Work Location: In person

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