Senior Documentation Engineer

vor 2 Wochen

Bern, Bern, Schweiz Hays Vollzeit CHF 150'000 - CHF 180'000 pro Jahr

Senior Documentation Engineer – Primary Packaging & Medical Devices (m/f/d)


Location:
Bern, Switzerland


Start Date:
January 2026


Duration:
12 months, with option for extension

Are you an experienced professional in documentation and design control for medical devices and primary packaging?
This is your opportunity to join a strategic project in a dynamic environment

Key Responsibilities

  • Support the selection, qualification, and implementation of new and existing primary packaging materials, medical devices, and combination products.
  • Maintain and update Design History Files (DHF) for legacy products.
  • Ensure compliance with regulatory standards (ISO 13485, 21CFR820, ISO14971, EU MDR).
  • Create, review, and approve design control documents (verification and validation protocols, risk management plans, change management plans).
  • Collaborate cross-functionally with Regulatory, QA, Manufacturing, and Supply Chain teams to manage design changes and compliance projects.
  • Analyze product complaints and perform root cause investigations.

What We're Looking For

  • Minimum 10 years of experience in medical device development within the pharmaceutical industry.
  • Strong expertise in Change Control, Post-Market Surveillance, and CAPA processes.
  • Proven track record in lifecycle management and continuous improvement of existing products.
  • Excellent organizational and communication skills; ability to work independently.
  • Solid scientific background in primary packaging and drug delivery systems.
  • Experience with design control documentation, risk management, and SOP writing.


Interested?
Apply now and contribute to shaping the future of drug delivery systems

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