We are seeking a highly skilled Principal Scientist Design to join our team in Dublin.
This exciting role will involve providing subject matter expertise to support the development of combination products, with a focus on mechanical design and development. The successful candidate will lead a team to plan and execute design verification and reliability strategies, and be responsible for the technical interface between drug product and device teams during combination product development.
The ideal candidate will have a strong background in science or engineering, preferably at Master's level, and significant experience in pharmaceutical and/or medical device development. They should also have working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485, as well as experience in the development and validation of analytical methods and the application of statistical techniques for data analysis.
In addition, the successful candidate will be experienced in writing and supporting regulatory submissions, and have a good understanding of the formulation and manufacturing development activities required for combination products.
To succeed in this role, you will need to have excellent communication and project management skills, as well as the ability to work effectively in a team environment.
Responsibilities:
* Provision of subject matter expertise to support the development of Combination Products
* Responsible for mechanical design and development of combination products.
* Leading a team to plan and execute design verification and reliability strategies.
* Responsible for the technical interface between drug product and device teams during combination product development, ensuring formulation and manufacturing development activities are compatible and align with device development.
* Responsible for the development of design requirements and specifications based on characterisation of comparator products, regulatory requirements, design intent and user requirements.
* Responsible for developing test methods and specifications to assess device functionality and product performance, implementing evaluation, procurement & implementing new, state-of-the-art lab testing equipment as applicable.
* Responsible for material assessment of device components, including biological evaluation, extractables profiling and material certification.
You will be an important member of our team, and we look forward to hearing from you.