Principal Development Engineer

CK Technical are recruiting for a Principal Development Engineer to join a company in the biopharmaceutical industry at their site based in Ware on a permanent basis.

The Company:

Our client is an in-house device development group charged with the delivery of robust, patient-centric devices that enable the effective delivery of novel pharmaceuticals.

Location:

This role is located in Ware with the opportunity to work from home when possible (1-2 days per week).

Principal Development Engineer Role:

Your main duties will be:

• Responsibility for the risk management files for pipeline products.
• Contributing to the development and population of the Design History File.
• Facilitating risk assessments.
• Resolvingchallenges in design, manufacturing and regulatory affairs.

Your Background:

The ideal candidate for this role will have

• A strong engineering background and a degree in an engineering subject (E.g. Mechanical Engineering, Biomedical Engineering).
• Experience in combination device development.
• Comprehensive understanding of relevant regulations and risk management processes (ISO14791, ISO13485, EU MDR).
• People and project management experience would be very beneficial.

Entitlement to work in the UK is essential. For more information or to apply for this Principal Development Engineer position, please contact George Truman on 01246 457730 or email cktech@ckgroup.co.uk. Please quote reference 52366.