Senior Design Assurance Engineer
Brief Role Description:
We are supporting our client who are a successful manufacturer of Safety Critical Components, in their search for a Senior Design Assurance Engineer to join their expanding team.
- Capture, analysis, generation and management of requirements to support product design and development
- Support and development of the requirements management tool and associated processes
- 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
- Guiding a multi-disciplinary team responsible for medical device development in accordance with ISO 13485
- A degree level qualification
- 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
- Demonstrable detailed knowledge of requirements engineering
- Practical experience of risk management, including FMEAs
- Broad knowledge encompassing engineering disciplines including mechanical, electrical and soft ware
- High attention to detail
- Exceptional communication, planning and organisational skills
- Leadership experience at a senior level: coaching and managing upwards and horizontally
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