Principal Scientist Design

Here, in Hays Recruitment, our Pharmaceutical client in Dublin is hiring a Principal Scientist Mechanical Design for combination products.

Your new role

Provision of subject matter expertise to support the development of Combination ProductsResponsible 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.

What you'll need to succeed

Degree in Science/Engineering (Master’s preferred)7+ years’ experience in pharmaceutical and/or medical device developmentWorking knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage.Experience in the development and validation of analytical methodsExperienced in the application of statistical techniques for data analysisExperience of writing and supporting regulatory submissions

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