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
EMPLOYMENT TYPE
Permanent
Principal 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.
Required Skills:
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Bachelor’s degree or equivalent in engineering or other technical/scientific area
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Proven experience (2+ years) in quality engineering or a related role in the medical device industry
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Strong understanding of regulations and standards affecting medical device development, in particular; ISO 13485, MDR 2017/745, 21 CFR 820, ISO 14971 and IEC 62366-1
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Familiarity with design control, risk management and usability engineering principles and experience in participating in design reviews
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Solid understanding of manufacturing processes, quality control methods, and statistical principles and techniques
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Excellent analytical, problem-solving, and decision-making abilities with strong attention to detail
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Excellent communication skills, both written and verbal, with the ability to effectively communicate with cross-functional teams