CSL Behring is seeking a Senior Engineer (Drug Delivery Lead) in Bern, Switzerland, responsible for leading the development of drug delivery systems with a focus on cross-functional collaboration. The ideal candidate will have significant experience in drug delivery device development and project leadership within regulated environments
Job Summary
Responsible for bringing new Drug Delivery Systems through the development process with considerable cross-functional interaction.
Application of expertise in Design Controls, Risk Management, EU MDR requirements, and compilation of Design History Files.
Provide leadership to Project Team to deliver submission-ready packages for Notified Bodies and regulators.
Matching Summary
Match Score: 85
CSL Behring is seeking a Senior Engineer (Drug Delivery Lead) in Bern, Switzerland, responsible for leading the development of drug delivery systems with a focus on cross-functional collaboration. The ideal candidate will have significant experience in drug delivery device development and project leadership within regulated environments.
Skills & Requirements
Must-have
Drug Delivery Systems development
Combination products and medical devices
Design Controls and Risk Management
ISO 13485, ISO 14971, 21 CFR 820
EU MDR requirements
Design History Files compilation
Submission-ready packages for regulators
Nice-to-have
Cross-functional team leadership
Independent and self-motivated
Strong organizational and communication skills
Key Requirements
Minimum of 7 years in drug delivery device development
Masters or PhD in Biomedical Engineering, Electrical or Mechanical Engineering
Experience in project leadership in a matrix organization