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Project Manager – External Manufacturing (Temp, Full‑time)

Congenius AG · Suisse centrale

Senior 🇬🇧 English
Lean Six Sigma ISO 13485 IVDR FDA 21 CFR Part 820 Risk management Project planning Budgeting Supplier management German English

Description du poste

About the role

We are looking for a Project Manager to lead product development projects for externally manufactured diagnostic consumables. The role is based in Central Switzerland and involves close collaboration with internal stakeholders, external suppliers, and procurement teams.

Key responsibilities

  • Manage one or more product development projects for externally manufactured diagnostic consumables.
  • Define and deliver product requirements and specifications in alignment with internal and external partners.
  • Lead design and industrialisation activities, including the set‑up of manufacturing lines at external sites.
  • Monitor project scope, timelines, budget, resources, quality and risks to ensure timely delivery.
  • Lead cross‑functional matrix teams and drive continuous improvement with internal and external partners.
  • Communicate project progress to stakeholders and support supplier selection and maintenance.

Required profile

  • Degree in Engineering, Natural Sciences or a related technical discipline (BSc or MSc).
  • Several years of project‑management experience in product development, manufacturing, MedTech, diagnostics or a regulated industry.
  • Knowledge of Lean, Six Sigma and in‑vitro diagnostic regulations (ISO 13485, IVDR, FDA 21 CFR Part 820).
  • Experience with external manufacturing, supplier management and industrialisation projects.
  • Strong knowledge of risk management, project planning, budgeting and stakeholder management.
  • Fluent in German and English, with willingness to travel internationally (10‑20%).

Required skills

  • Lean
  • Six Sigma
  • ISO 13485
  • IVDR
  • FDA 21 CFR Part 820
  • Risk management
  • Project planning
  • Budgeting
  • Supplier management
  • Industrialisation
  • German (language)
  • English (language)

What we offer

  • Work in a dynamic, ambitious company with a flat hierarchy.
  • Versatile field of activity in the MedTech sector.
  • Pleasant working atmosphere and collegial cooperation.
  • Modern and attractive working conditions.
  • Attractive salary and very good social benefits.
  • One‑year fixed‑term contract with high likelihood of extension.

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Congenius AG

Suisse centrale