Senior Engineer (drug Delivery Lead)

CSL SEQIRUS

Bern, Switzerland
Hybrid
Drug delivery device development
Combination products
Design controls
Responsible for planning and execution of projects for evaluation, selection, improvement, and implementation of new or existing primary packaging materials, medical devices, and Combination Products for CSL products

Job Summary

  • Responsible for planning and execution of projects for evaluation, selection, improvement, and implementation of new or existing primary packaging materials, medical devices, and Combination Products for CSL products.
  • Provide leadership to ensure the coordination of activities and information between the functions and with external partners.
  • You Belong at CSL: Inclusion and Belonging is at the core of our mission and who we are, fueling innovation day in and day out.

Matching Summary

Responsible for planning and execution of projects for evaluation, selection, improvement, and implementation of new or existing primary packaging materials, medical devices, and Combination Products for CSL products.

Skills & Requirements

Must-have

  • Drug Delivery Device Development
  • Combination Products
  • Design Controls
  • Risk Management
  • Regulatory Affairs Support
  • Cross-functional Collaboration

Nice-to-have

  • Respiratory Drug Delivery Background
  • Project Leadership in Matrix Organization
  • Independent and Self-Motivated
  • Strong Organizational Skills

Key Requirements

  • Minimum 7 years drug delivery device development
  • Masters or PhD in relevant engineering field
  • Experience with ISO 13485, ISO 14971, 21 CFR 820
  • Experience with EU MDR requirements
  • Experience supporting regulatory submissions

Work Rights

Not specified

Tailored Resume

Cover Letter