Risk Management Engineer
4 weeks ago
Sinclair are currently recruiting for a Risk Management Engineer in the UK with once a month travel to their Chester or London office dependent on where the candidate is located. This is a 6 months fixed term contract. The Risk Management Engineer will report into the Risk Manager to contribute directly to meeting regulatory submission and launch timelines of medical devices and aesthetic products. The Risk Management Engineer is responsible for maintaining risk management activities for legacy devices and supporting new product development activities.
The ideal candidate will have a minimum of 5 years’ experience in the regulated medical device industry and knowledge of usability engineering for medical devices. As well as experience in performing risk management for medical devices.
Location: Once a month at either of our offices 30-32 Whitfield Street, London, W1T 2RQ/ Eden House, Lakeside, Chester Business Park, Cheshire, CH4 9QT
About Sinclair
Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.
This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.
Our Vision
Providing aesthetic excellence globally.
Our Mission
Driving the advancement of product quality and customer satisfaction, investing in innovation and people.
Our Values
- Act with Integrity
- Be results driven
- Embrace your winning spirit
- Stay ahead of the game
- One team, one goal
• Lead and coordinate all risk management activities according to ISO 14971.
• Plan, prepare and perform risk management for medical devices and aesthetic products according to project phases following all relevant internal procedures,
processes, and external requirements for development products.
• Represent Risk Management on assigned development projects.
• Establish risk acceptance criteria for individual residual risks and the overall
residual risk for specific devices in development and for legacy devices
• Maintain a close link to the Human Factors / Usability Engineering process to meet
the needs and ensure the safety of all users and patients.
• Support creation of device design specifications to ensure that risk control
measures are appropriate.
• Monitor that risk control measures have been implemented, verified, and validated.
• Maintain knowledge of current Company policies, standards and guidelines as well
as industry practices, regulatory requirements, and other relevant information.
• Ensure harmonized approaches to risk management across projects.
• Communicate with Research and Development team members on other projects to share lessons learned and ensure use of common tools and ideas within the team.
Ensure that the risk management process incorporates all relevant data from the
• Design Authorities e.g., Design FMEAs, Security Risk Analysis, Use-related risk
analysis, formative human factors evaluations and human factors validation
studies.
• Ensure that risk management reports are prepared in a timely manner and in
accordance with ISO 14971 and applicable Company SOPs and guidelines and
are adequate for inspection by notified bodies and other relevant authorities.
• Present project-specific risk management activities at regulatory body inspections
and internal audits.
• Work cross-functionally with other global functions: e.g., Global Marketing, Global
• Regulatory Affairs, Clinical Affairs and Manufacturing.
• Support a good link between risk management during development and risk
management for marketed products.
• Ensure that all hazards associated with a medical device and aesthetic products are identified, the associated risks are estimated and evaluated and that these
risks are controlled; monitors that these risk controls are implemented, verified and validated.
• Assures that Company quality and compliance standards and applicable government regulations are met by means of independent risk management for
medical devices under development.
Performs risk management in medical device and aesthetic projects and assists medical device sites in ensuring that risk management is performed in sufficient detail and in a timely manner for new device introductions and regulatory agency inspections.
• Has overall responsibility that medical devices and aesthetic products are designed to be safe, effective and in compliance with the applicable regulations worldwide.
Your Skills & Experience – Do You Have What it Takes?
Essential :
• Minimum of 5 years of experience in regulated medical device industry
• Experience in performing risk management for medical devices
• Knowledge of usability engineering or human factors engineering for medical devices
• Knowledge in usage of risk assessment methods
• Specific knowledge of active medical devices
If this sounds like you and you meet the requirements, please apply, we would love to hear from you.
Please note if we receive a high volume of applications, we may close the role before the closing date noted.
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