Risk Engineer (Medical, Auto, Safety-critical, MDD, ISO13485)

Recruiter
We Are SSG
Location
Warwickshire
Salary
40000.00 GBP Annual
Posted
14 Mar 2018
Closes
28 Mar 2018
Sector
Engineering
Contract Type
Permanent

Risk Engineer (Medical, Auto, Safety-critical, MDD, ISO13485)

Warwickshire

GBP50k + bonus + benefits

This is a fantastic opportunity to join a fast growing, innovative, high technology medical devices company, developing an advanced system for use both in the home and in medical centres that will significantly improve the quality of life of the patients involved. The product is unique and set to make a significant impact on a multi-billion dollar global market.

They now require an experienced Risk Engineer to coordinate risk management activities ensuring they are appropriately documented and to provide technical support to Engineering, Operations, Quality and Regulatory teams in helping the company achieve compliance with regulatory standards.

Responsibilities

  • Ensure compliance of risk-based processes to the requirements of ISO14971 and ISO 13485 and regularly review these processes for ongoing acceptability
  • Assist the regulatory and risk manager in ensuring compliance of the company medical products to other relevant technical standards, especially where these require risk based arguments - IEC 60601, BS EN 62366-1, BS EN 62304
  • Oversee the creation and updating of risk management documents as necessary
  • Ensure that product - based risk control measures are implemented and proven as effective
  • Ensure that the risk management process utilises all necessary inputs and outputs (CAPA, Vigilance).
  • Assist all company members to fully understand risk management processes and in understanding relevant aspects of regulatory standards.

Qualifications

  • A relevant degree, preferably in science or engineering or equivalent work history.
  • Experience or working understanding of ISO 14971 & ISO 13485
  • Familiarity with the Medical Device Directive (MDD) or Medical Device Regulations (MDR)
  • Familiarity with risk management requirements in other international standards relevant to medical devices e.g. BS EN 62366-1, BS EN 62304 and IEC 60601.
  • Experience with MS Office software particularly Word and Excel. Familiarity with specialist risk management software is desirable but not essential.
  • Ability to view problems from multiple perspectives
  • Strong analytical skills with keen attention to detail
  • Good communication and team working skills

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