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Design Assurance Engineer

One of my key clients are currently seeking an experienced Design Assurance Engineer to join their team, on an initial 6 month hourly rate contract. The company are ranked within the top 10 medical device companies worldwide, and specialise in the manufacture of cardiovascular products, including stents and catheters.

Your role as a Design Assurance Engineer will be to act as part of the Quality Function onsite. You will be responsible for providing input to cross functional teams, in the design of a variety of medical devices.

Role: Design Assurance Engineer

Location: Galway

Contract: An initial 6 month hourly rate contract

Responsibilities:

  • Plan, conduct and execute design assurance activities, and provide judgement in the independent evaluation, and selection of adaptation to the mechanical engineering techniques and testing procedures.
  • Work closely with the product development teams, to establish the system design specifications and product requirements.
  • Liaise with the engineering teams on site to establish and review the design FMEA.
  • Support various QA / RA activities including Quality Management, System reviews and audits.
  • Evaluation of new products, ensuring the safety and efficacy of the devices.
  • Design verification and shelf life protocols.
  • Support customer complaint analysis and post market surveillance activities.
  • Generate and approve change requests.
  • Root cause analysis.

Requirements:

  • 5+ years experience within a Design Assurance position within the medical device / pharmaceutical industry.
  • Bachelors degree in Science / Engineering disciplines.
  • Proven ability to work as part of a team, and as an individual.
  • Good knowledge of design control processes / risk management processes.

No CV ready? Not sure yet? Feel free to contact me for further details.

This role is an excellent opportunity to work alongside an innovative engineering team within a leading medical device company, with exposure to both new products, and post market surveillance.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales