Senior Design Assurance Engineer

Job Reference: WM - 2297

Location: Cambridge

Salary: £60,000 - £65,000

Job Type: Permanent

Job Description

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.

Responsibilities:

  • 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

About You:

  • 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

Job Application:

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