Principal Engineer, Tech Ops (drug Delivery Systems Testing & Verification)
CSL Behring
Multiple Locations
**
Develop and validate test methods
Medical device standards knowledge
Technical documentation authoring
**
CSL Behring is seeking a Principal Engineer in Tech Operations for Drug Delivery Systems Testing & Verification. The role involves developing, validating, and executing test methods for medical devices and requires a minimum of 5 years of experience in the medical device/pharmaceutical industry.
**
Job Summary
The Principal Engineer plays an important role in the medical device and primary packaging development process to deliver specialized testing results from exploratory characterization to design verification results to support regulatory submission packages.
Develop, validate, transfer, and life cycle of test methods for vials, transfer devices, e.g., vial-to-vial transfer, syringes, needle-safety devices, autoinjectors, and on-body drug delivery systems.
Author and review rigorous technical documents for inclusion in DHFs, to support regulatory submissions, and to address regulatory inquiry.
Matching Summary
Match Score: 75
**
CSL Behring is seeking a Principal Engineer in Tech Operations for Drug Delivery Systems Testing & Verification. The role involves developing, validating, and executing test methods for medical devices and requires a minimum of 5 years of experience in the medical device/pharmaceutical industry.
**
Skills & Requirements
Must-have
Develop and validate test methods
Medical device standards knowledge
Technical documentation authoring
Specialized test fixture design
Laboratory operations support
Nice-to-have
Applied statistics and software experience
Prototyping and optical measurement
Mechanical aptitude and safety systems
Collaborative team environment skills
Key Requirements
Degree in Engineering, Natural Sciences, Pharmacy, or other relevant area
At least 5 years of related experience in medical device development and testing