Design and deliver combination products from concept through to design transfer
A global pharmaceutical company is hiring a Device Design Engineer into its device design and industrialisation function, based in Cambridge. The role supports a portfolio of programmes including complex injectables and feasibility projects. You will work within cross-functional programme teams, taking technical ownership of design and documentation through to stage gates and regulatory submission milestones. The impact is high-quality, right first time submissions and robust, manufacturable devices.
What You Will Do
- Develop combination products from concept generation through to design transfer.
- Produce fully dimensioned 2D technical drawings and specifications, applying GD&T to ensure manufacturable designs.
- Resolve design challenges using root cause analysis, hand calculations, tolerance analysis, CFD and FEA.
- Represent device design within cross-functional programme teams, supporting planning and execution of design activities.
- Identify, assess and mitigate technical risks in line with ISO 14971, including hazard analysis and dFMEAs.
- Create, review and approve Design History File documentation, including change controls, BOMs and technical reports.
- Build and test prototype components and devices, using data to refine and improve designs.
- Deliver right first time submission packages and close out peer review feedback.
What We're Looking For
- Design engineering or product development background, with end-to-end combination product experience from concept to design transfer.
- Higher Diploma, Bachelor's or Master's degree (2.1 or higher) in product design, mechanical or biomedical engineering, or a related science.
- Strong CAD proficiency, including detailed 2D drawings and a thorough understanding of GD&T.
- Hands-on experience with root cause analysis, hand calculations, analytical modelling and tolerance stack-up analysis.
- Experience creating and reviewing Design History File documentation, component drawings, change controls and BOM management.
- Working knowledge of ISO 13485 quality management systems and design controls aligned with medical device regulations.
- Clear technical communication and stakeholder management across multidisciplinary teams.
- Willingness to travel regularly between sites in the UK and Ireland, with occasional international travel.
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