Risk Management (Quality, Test, Design) Engineer - Medical Devices - London
Our client is an established medical device company with a revolutionary and advanced active medical device product sold globally. They invest in their R&D division and have won several awards for innovation.
They are looking for someone with an understanding and passion for risk management - they will consider someone with a background within med-tech quality, design or test to transition into this progressive position.
This is a great time to be joining an established medical device company in a developing role within risk management - ISO 14971.
Please apply today or contact email@example.com for further details.
Risk Management Engineer - ISO 14971
Circa £40,000 per annum plus benefits - candidates seeking more or less will also be considered (with medical device experience).
Our client is looking for a professional with an understanding of risk management within medical devices. Appreciating that this role is specialist, our client is considering risk specialists as well as applicants with a background within medical device product development or engineers or quality / reg specialists with ISO 14971 who are looking to progress within a more specialist role. The ideal applicant will also have;
- A good understanding of medical device design and development requirements
- A degree level education within an engineering field
- Strong organisation skills and high-level attention to detail
- Ability to work across multi-disciplinary teams to support delivery of projects
- Excellent communication and presentation skills
Reporting to the Director of Compliance, responsibilities include;
· Develop an understanding of products in development, its marketed comparators, and the potential risks associated with design, manufacture and use of the product
· Enhance risk management principles and processes, ensuring that risk management is at the core of all device development activities
· Monitor and review changes to regulations and standards and make recommendations for maintaining compliance for risk management
· Maintain risk management procedures, and related templates and forms
· Support all risk management activities for full product lifecycle including:
o Maintenance of the risk management file
o Maintenance of the risk management plan
o Provide qualitative and quantitative analysis of potential hazards identified from usability studies, post market surveillance and design changes
o Maintenance of the register of risks
o Input to impact analysis of design changes
o Risk review of residual anomalies and test deviations
o Participation in formal design reviews and project meetings as required
o Generation of risk management reports
o Post market surveillance
· Support queries made concerning safety evaluations from the complaint handing team
· Support safety related investigations made in by the quality management department when investigating non-conformances, observations and CAPA
· Contribute to, and participate in health hazard evaluations as required
· Support, when required, other risk processes, including usability engineering, production risk management, and cybersecurity.
Indo Professionals is dedicated to the medical technology market focused on placing regulatory, quality assurance, clinical research and related professionals. Please contact us today to discuss your next career challenge.