Senior Engineer (drug Delivery Lead)

CSL Behring

Bern, Switzerland
Hybrid
7 years drug delivery device development
Design controls iso 13485 iso 14971
Eu mdr regulatory requirements
This role is responsible for bringing new Drug Delivery Systems through the development process with mandatory three-day office presence in Bern, Switzerland

Job Summary

  • This role is responsible for bringing new Drug Delivery Systems through the development process with mandatory three-day office presence in Bern, Switzerland.
  • The position requires applying expertise in Design Controls, Risk Management, and EU MDR requirements to deliver submission-ready packages for regulators.
  • CSL Behring is a global biotherapeutics leader employing over 32,000 people dedicated to saving lives through innovative therapies.

Matching Summary

This role is responsible for bringing new Drug Delivery Systems through the development process with mandatory three-day office presence in Bern, Switzerland.

Skills & Requirements

Must-have

  • 7 years drug delivery device development
  • Design Controls ISO 13485 ISO 14971
  • EU MDR regulatory requirements
  • Cross-functional project leadership
  • Primary packaging and combination products

Nice-to-have

  • Respiratory drug delivery background
  • Matrix organization experience
  • Root cause analysis tools
  • Tolerance analysis expertise
  • Self-motivated independent worker

Key Requirements

  • Masters or PhD in Biomedical/Electrical/Mechanical Engineering
  • Minimum 7 years in drug delivery device development
  • Experience in highly regulated pharma environment
  • Strong English communication skills

Work Rights

Not specified

Tailored Resume

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