Job Title: Principal Scientist Design
Lead a team in designing combination products, overseeing development and verification.
* Contribute subject matter expertise to the development of Combination Products.
* Design and develop combination products with mechanical expertise.
* Plan and execute design verification and reliability strategies.
* Ensure technical compatibility between drug product and device teams.
* Develop design requirements and specifications based on regulatory needs.
* Create test methods for assessing device functionality.
* Assess device components for material suitability.
Requirements:
* Degree in Science/Engineering (Master's preferred).
* 7+ years' experience in pharmaceutical and/or medical device development.
* Working knowledge of design control requirements.
* Experience in analytical method development and validation.
* Data analysis skills using statistical techniques.
* Regulatory submission support experience.
About this role:
This is an exciting opportunity to lead a team in designing innovative combination products. As a key member of our team, you will be responsible for driving the development of Combination Products from concept to market.