Project Manager - Plan-les-Ouates, Schweiz - Spineart SA

Spineart SA
Spineart SA
Geprüftes Unternehmen
Plan-les-Ouates, Schweiz

vor 1 Woche

Lena Schneider

Geschrieben von:

Lena Schneider

beBee Recruiter
Beschreibung

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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