20
206030 Fresenius Kabi SwissBioSim GmbH
2 Monate

Senior Manager Medical Device Program Lead(m/w/x)

Vollzeit
Senior
Keine Angabe
Eysins

In this role, you will lead device development projects from concept to production, collaborating with cross-functional teams to ensure quality and compliance. Your daily responsibilities will include managing timelines, budgets, and risks while driving innovation and improvement initiatives.

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Anforderungen

  • Bachelor’s degree or equivalent in Product design, Mechanical, Process, Materials Science or Electronic Engineering
  • 5+ years of experience in project management
  • 10+ years of experience in device development with understanding of device safety and regulatory requirements
  • Deep technical understanding of device design, validation, verification and their link to drug development activities
  • Experience in FDA regulated medical devices and combination drug device products
  • Track record of resolving issues in a matrix organization
  • Strong interpersonal and relationship building skills
  • Solid organizational skills including attention to detail and multi-tasking skills
  • Effective verbal and written communication
  • Fluency in English; additional languages (German or French) are an asset
Bachelor-Abschluss

Berufserfahrung

10 Jahre

Deine Aufgaben

  • Lead cross-functional exercises to define targeted device profiles
  • Develop project plans and budgets with internal and external teams
  • Deliver quality products and processes with proper validation and regulatory documentation
  • Report and control device development timelines, budgets, and risks
  • Act as the main interface between biosimilars project teams and subteams
  • Provide technical and business inputs to projects
  • Analyze risks and suggest mitigation plans
  • Oversee device development, manufacturing, validation, and regulatory activities
  • Proactively identify risk areas and alert stakeholders
  • Report and escalate potential issues to management
  • Identify new device opportunities
  • Lead innovation and continuous improvement projects

Sprachen

DeutschGrundkenntnisse

Englischverhandlungssicher

FranzösischGrundkenntnisse

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