SENIOR DESIGN ENGINEER

We are a specialist agency providing design & development of medical devices. We work alongside leading clinicians, pharma and med-tech providers to develop ground breaking new healthcare solutions. With major projects ongoing, and demand increasing, we are looking for new people to join the team., * Take the lead in devising novel technical solutions to complex design challenges, and perform a lead role in delivering narrative to the client as solutions evolve.

• Drive solutions through to verification, validation and production transfer.
• Work effectively with Fearsome colleagues, provide leadership and mentorship to less experienced members of the team.
• Collaborate effectively with the client, clinicians and other external stakeholders to ensure solutions align with their needs.
• Take ownership of elements of design control, usability and risk engineering and produce documentation according to the relevant EU, US and UK regulatory requirements.

• Background in mechanical engineering, biomedical engineering, product design or similar.
• Aptitude, bravery and enthusiasm for solving complex technical problems, including hands-on R&D, iterative prototyping and lab testing.
• High work ethic and uncompromising drive to produce excellent results.
• Honest and open communication style.
• Experience in design & development of medical devices, in particular drug delivery systems.
• Knowledge of materials selection and testing considerations for invasive and implantable devices.
• Experience in DFM, as well as design to manufacture transfer, across relevant manufacturing processes and materials.
• Experience in verification and validation of high risk medical devices.
• Experience in design control according to ISO 13485.
• Working knowledge of IEC 62366-1 usability engineering and ISO 14971 risk management., * Degree in Mechanical Engineering, Biomedical Engineering, or similar
• 4-8 years’ experience in medical device design and development
• Experience with drug delivery technologies (e.g., injection systems, fluid handling, dose accuracy mechanisms)
• Strong CAD skills and experience with prototyping methods
• Understanding of materials, tolerancing, and design for manufacture (DFM)
• Familiarity with regulated development environments