Combination Product Specialist/Expert
Listed on 2026-05-18
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Engineering
Biomedical Engineer, Medical Device Industry
The Combination Device Specialist/Expert function is responsible for the development and support of drug delivery devices across a diverse product portfolio. Activities span multiple engineering disciplines, covering the full product lifecycle from early concept and requirements definition through to commercialisation and post-market support.
Within this function, the Device Engineering team focuses on the design, engineering, testing and manufacturing of safe, reliable drug delivery devices that meet the needs of patients, healthcare professionals and regulatory bodies.
This role offers an excellent opportunity for an early- to mid-career engineer to develop their skills within a cross-functional and regulated environment. You will work closely with colleagues from Quality, Regulatory Affairs, Clinical and Commercial teams, contributing to the development of combination products and medical devices.
Reporting to a Device Engineering manager, you will support device development projects and contribute technical expertise under guidance from more experienced engineers.
Key responsibilities include:- Contributing to the development of combination products and medical devices from concept through to commercialisation
- Supporting the evaluation and application of new or emerging technologies for drug delivery devices
- Applying engineering principles to help define product requirements and develop design solutions that meet performance and quality expectations
- Preparing and maintaining design control documentation, such as design plans, user requirements, design inputs/outputs, verification documentation and design history files
- Supporting risk management, conformity assessments and design verification activities
- Assisting with project planning activities and delivering assigned tasks within agreed timelines, quality standards and budget constraints
- Working in accordance with applicable quality and regulatory requirements and standards (e.g. ISO and FDA design control requirements)
- You hold a university degree in engineering or a related technical discipline
- You have initial professional experience (typically around 2–4 years) in mechanical engineering, device development or a closely related field, ideally within a regulated environment
- Exposure to drug delivery devices (e.g. pen injectors, auto-injectors or similar medical devices) is an advantage, but not essential
- You have a basic understanding of quality systems, regulatory requirements and industry standards relevant to medical devices or combination products
- You are comfortable working with technical documentation and are willing to develop strong design control and compliance skills
- You demonstrate good analytical, problem-solving and communication skills and enjoy working collaboratively in cross-functional teams
- You have a good command of English; additional language skills are considered a plus
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