Job Overview
A Principal Scientist Design position involves providing subject matter expertise for combination product development, leading a team, and ensuring technical interfaces between drug product and device teams.
* Masters degree in Science/Engineering or equivalent experience required.
* 7+ years pharmaceutical and/or medical device development experience needed.
Key Responsibilities
1. Provision of subject matter expertise to support combination product development.
2. Responsible for mechanical design and development of combination products.
3. Leading a team to plan and execute design verification and reliability strategies.
4. Technical interface between drug product and device teams during combination product development.
5. Development of design requirements and specifications based on characterisation of comparator products, regulatory requirements, design intent, and user requirements.
6. Developing test methods and specifications to assess device functionality and product performance.
7. Material assessment of device components, including biological evaluation, extractables profiling, and material certification.