Your new role

• 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.

What you'll need to succeed

• Degree in Science/Engineering (Master’s preferred)
• 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 would be an advantage.
• Experience in the development and validation of analytical methods
• Experienced in the application of statistical techniques for data analysis
• Experience of writing and supporting regulatory submissions

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.