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.
LOCATION
Glasgow/ Hybrid
EMPLOYMENT TYPE
Permanent
Aspects Of The Role
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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.
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Drive solutions through to verification, validation and production transfer.
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Work effectively with Fearsome colleagues, provide leadership and mentorship to less experienced members of the team.
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Collaborate effectively with the client, clinicians and other external stakeholders to ensure solutions align with their needs.
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Take ownership of elements of design control, usability and risk engineering and produce documentation according to the relevant EU, US and UK regulatory requirements.
An ideal candidate might possess:
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Background in mechanical engineering, biomedical engineering, product design or similar.
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Aptitude, bravery and enthusiasm for solving complex technical problems, including hands-on R&D, iterative prototyping and lab testing.
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High work ethic and uncompromising drive to produce excellent results.
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Honest and open communication style.
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Experience in design & development of medical devices, in particular drug delivery systems.
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Knowledge of materials selection and testing considerations for invasive and implantable devices.
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Experience in DFM, as well as design to manufacture transfer, across relevant manufacturing processes and materials.
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Experience in verification and validation of high risk medical devices.
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Experience in design control according to ISO 13485.
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Working knowledge of IEC 62366-1 usability engineering and ISO 14971 risk management.