Lead Combination Product Development
As a Principal Scientist Design, you will provide subject matter expertise to support the development of combination products.
* Lead the mechanical design and development of combination products.
* Oversee a team to plan and execute design verification and reliability strategies.
* Maintain a technical interface between drug product and device teams during combination product development.
* Develop design requirements and specifications based on comparator product characterization, regulatory requirements, and user needs.
* Implement test methods and specifications to assess device functionality and product performance.
* Evaluate material suitability for device components.
Qualifications and Skills
* Degree in Science or Engineering (Master's preferred)
* 7+ years' experience in pharmaceutical and/or medical device development.
* Familiarity with FDA 21 CFR part 820 and ISO 13485 design control requirements is advantageous.
* Experience in analytical method development and validation.
* Skilled in statistical data analysis techniques.
* Regulatory submission writing and supporting experience.