Senior Design Assurance Engineer
- Guiding a multi-disciplinary team responsible for medical device development in accordance with ISO 13485
- Capture, analysis, generation, and management of requirements to support product design and development
- Planning, coordinating, and delivering quality, value-added project risk management deliverables, including FMEAs and Hazards Analysis, per ISO14971
- Bridging the gap between the Regulatory and Technology functions, communicating efficiently and effectively with both departments to ensure the right outcome
- Applying strong analytical skills and engineering knowledge to define problems, collect data, establish facts, and draw valid conclusions
- This is a high growth company and as such roles change and evolve. The successful candidate would be expected to be willing to turn their hand to anything within the Systems and Technology team remit that helps the team deliver its objectives.
- A degree level qualification
- Experience in a highly regulated industry (medical, automotive, aerospace)
- Broad knowledge encompassing engineering disciplines including mechanical, electrical and software
- Leadership and management experience at a senior level: coaching and managing upwards and horizontally
- Demonstrable detailed knowledge of requirements engineering
- Practical experience of risk management, including FMEAs
It would also be helpful if you have:
- Working knowledge of ISO standards, FDA, MDD and MDR regulations applicable to the design and development of medical devices
- Experience using a requirements management or ALM tool
- High attention to detail
- Exceptional communication, planning and organisational skills
If you would like to be considered for this role, please apply to send a copy of your full CV – or call us now.
Whilst this position may not be of interest to you or suit your skills and experience, please don’t hesitate to get in contact with a member of the team at Willcox Matthews to understand how we can support you.
We receive a large number of applications for all of our positions – Therefore, If you have not received a response within 10 working days, your application has unfortunately been unsuccessful on this occasion.
Candidates must be eligible to work and live in the UK