Our client is seeking a Principal Scientist to support the development of Combination Products.
Key Responsibilities:
* Provide subject matter expertise for Combination Product development.
* Lead mechanical design and development of combination products, ensuring compatibility with drug product and device teams.
* Plan and execute design verification and reliability strategies for combination products.
* Develop design requirements and specifications based on characterisation of comparator products, regulatory requirements, design intent and user requirements.
* Design and implement test methods and specifications to assess device functionality and product performance.
* Assess material components, including biological evaluation, extractables profiling and material certification.
Requirements:
* Master's degree in Science or Engineering
* 7+ years' experience in pharmaceutical and/or medical device development
* Working knowledge of design control requirements
* Experience in analytical method development and validation
* Statistical techniques for data analysis and regulatory submissions