Project Manager

vor 2 Monaten

PlanlesOuates, Schweiz Spineart SA Vollzeit

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 complex 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
- Execute or 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 and manage 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 (incl. NC analysis),
- Support to Operations, Process Validation Support and Marketing

**Profile**
- Mechanical Engineering degree or equivalent
- 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 - 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

Type d'emploi : 100%, CDI

Programmation:

- Période de travail de 8 Heures

Capacité à faire le trajet ou à déménager:

- 1228 Plan-les-Ouates: Faire le trajet sans problème ou prévoir un déménagement avant de prendre son poste (Exigé)

Question(s) de présélection:

- Did you already worked in the domain of Medical devices (Spine industry or Orthopedic)

Expérience:

- Project management: 5 ans (Exigé)

Langue:

- l'anglais et le francais couramment (Exigé)

Lieu du poste : Télétravail hybride (1228 Plan-les-Ouates)

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