Senior R&D Engineer- Combination Product
Senior R&D Engineer - Combination Products (Device Focus) - Contract/Freelance
Location: Copenhagen, Denmark
Contract Duration: 12 months- full time, 40 hours p/w
Start Date: ASAP
The Role
An opportunity has opened for an R&D consultant with combination product experience to support development work on injection-based delivery systems.
You'll join an established project team and contribute to ongoing R&D activities across the device side, including design updates, testing, and documentation. The work will focus on progressing development in line with design control requirements and supporting verification activities.
The role involves close collaboration with engineers, quality, and drug product teams, with a practical focus on moving development work forward rather than early-stage concept work.
This role sits firmly within R&D and will involve hands-on contribution across the full product development lifecycle, from early design through to verification and design transfer.
Key Responsibilities
- Contribute to the design and development of combination products, with ownership of the device constituent
- Execute and support core R&D activities, including:
- Concept development and design refinement
- Design verification & validation (V&V)
- Prototype development and testing
- Drive design control deliverables, ensuring traceability from requirements through to verification
- Perform and support risk management activities (ISO 14971), including design and use-related risk analysis
- Collaborate with cross-functional R&D teams across:
- Mechanical / device engineering
- Drug product / formulation
- Quality and regulatory
- Support human factors engineering (HFE) and usability studies as part of the development process
- Work closely with manufacturing teams on design transfer, scale-up, and industrialisation
Required Experience
- Strong track record within R&D for medical devices or combination products
- Hands-on experience developing:
- Injection devices, drug delivery systems, or similar mechanical devices
- In-depth understanding of:
- Design controls (DHF, requirements, traceability)
- Verification & validation processes
- Regulated development environments (ISO 13485, MDR/FDA)
- Experience working across the interface of device engineering development
Preferred Background
- Experience working within device-heavy MedTech organisations
- Exposure to platform-based delivery systems (e.g. pen injectors, autoinjectors, wearable injectors)
- Background in mechanical engineering, biomedical engineering, or similar
- Experience in early-stage development as well as late-stage / lifecycle R&D