We are in collaboration with an outstanding multinational R&D organisation based in Cambridge, UK. Together we are on the hunt for a talented Principal Human Factors Engineer who will be leading HF engineering activities for established medical devices (inc software MDs) and combination products - MDCPs.

This opportunity will allow you to team up with cross functional development groups, interacting with colleagues of all levels, always ensuring MDCP actions are complaint with quality and regulatory standards and contributing to the overall human factors research including laboratory testing and external exploration.
 

This role will offer you:

· Influence over continuous improvement activities (design validation/human factors).

· A culture that encourages, supports and empowers employees.

· Flexible hybrid working arrangement.

You will be responsible for:

· Leading human factors engineering activities for MDCP programs, ensuring deliverables are correctly drafted, accepted and nurtured in support of clinical trials and commercial endorsement.

· Providing device utility input and support to device design inputs and specifications.

· Championing risk management procedures for usability of assigned devices.

· Assisting with all design validation activities for assigned projects.

· Supporting all human factors (HF) activities associated with HF partners.

· Project management support (supply, assembly and testing of materials used in HF studies).

· Planning and performing full change control for IFU documentation where applicable.

· Handling device design and manufacturing investigations, internal/external audits of the Global Technology & Engineering (GT&E) team and the Devices quality systems.

You will bring the following:

· BSc/MSc/PhD in a related Science/Engineering discipline (Chemistry, Biochemistry, Biomedical, Mechanical, Materials, Chemical Engineering, Human Factors, Ergonomics, Industrial Design etc.) with a minimum of 2-5 years relevant experience in Pharmaceutical Combination Product and/or Device industries.

· Working knowledge of ISO standards and the EU Medical Devices Directive.

· Experience working in a GMP environment with proficiency in general computer software.

· High attention to detail, communicative and collaborative ability, comfortable working on multiple tasks concurrently.

· Desirable – Knowledge of current US and global regulations, FDA and ICH guidance, ISO standards (syringes/injectors, luer connectors) and quality system regulations for combination products.

· Desirable – Experience in Risk Management and Design Controls for Medical Devices and Combination Products.

Please use the contact details below if you would like to learn more about this opportunity and don’t forget to share this with all your talented Human Factors Engineers.

Email: lewis.besbeech@biotalent.com

Telephone: +44 (0)2037289989 or +44 (0)2033438780

BioTalent Ltd are acting as an employment agency in relation to this opportunity.