Design Verification and Reliability Strategist
Job Description:
* Develop technical interfaces between drug product and device teams during combination product development.
* Create design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements.
* Design test methods and specifications to assess device functionality and product performance.
* Material assessment of device components, including biological evaluation, extractables profiling and material certification.
Responsibilities Include:
* Leading a team to plan and execute design verification and reliability strategies.
* Working closely with cross-functional teams to ensure formulation and manufacturing development activities are compatible and align with device development.
* Developing analytical methods and applying statistical techniques for data analysis.
Requirements:
* Master's degree in Science or Engineering.
* At least 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 is an advantage.