Job Opportunity:
We are seeking a highly skilled professional to fill the role of Principal Scientist Design, with expertise in mechanical design and development of combination products.
About the Role
As a key member of our team, you will provide subject matter expertise to support the development of Combination Products. Your responsibilities will include:
1. Providing mechanical design and development for combination products.
2. Leading a team to plan and execute design verification and reliability strategies.
3. Serving as a technical interface between drug product and device teams during combination product development.
4. Developing design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent, and user requirements.
5. Creating test methods and specifications to assess device functionality and product performance.
6. Evaluating material assessment of device components, including biological evaluation, extractables profiling, and material certification.
Requirements
* Degree in Science/Engineering (Master's preferred)
* 7+ years' experience in pharmaceutical and/or medical device development
* Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage.
* Experience in the development and validation of analytical methods
* Experienced in the application of statistical techniques for data analysis
* Experience of writing and supporting regulatory submissions