[Hiring] Technical Reviewer - Active Medical Devices @BSI

Role Description

We exist to create positive change for people and the planet. Join us and make a difference too!

BSI is seeking experienced R&D Engineers to join our Active Medical Devices team as a home-based Technical Specialist & Scheme Manager (Technical Reviewer). If you have hands-on experience in the Research, Design, or Manufacture of Active Medical Devices, we'd love to hear from you.

As a Technical Reviewer, you will work with medical device manufacturers throughout their certification life cycle to place active medical devices on the European market. This position applies a mix of engineering and design knowledge, newfound regulatory expertise, English writing skills, client and project management. You will assess cutting-edge technology that will make a difference in patient health and safety and broaden your technical knowledge through ongoing training.

Responsibilities

• Review and evaluate medical device technical and clinical documentation in your areas of competence to assess compliance with MDD 93/42/EEC, MDR 2017/745 and UK MDR 2012 schemes.
• Manage certification activities for a portfolio of medical device manufacturers, including determination of auditing requirements and making recommendations for the issue and maintenance of CE certifications.
• Provide specialist regulatory, operational and strategic support to medical device scheme managers, product specialists and the business in the delivery of CE medical device marking schemes.
• Provide Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel.

Qualifications

• A minimum of 5 years of design and development or research and development or testing experience with a variety of active medical devices.
• Bachelor’s degree (or higher) in a discipline relevant to medical device manufacture and use, which may include:
  • Electronic/Electrical Engineering
  • Electro-mechanical Engineering
  • Biomedical Engineering
  • Medical Physics
• Thorough knowledge of Medical Device regulation; at minimum an awareness of the requirements of IEC 60601 Third Edition and the risk management standard ISO 14971.
• Understanding of the principles of design control and risk management.
• Strong interpersonal communication skills.
• Ability to prioritize and execute individual workload.

Requirements

• R&D experience across respiratory devices (e.g., ventilators, anaesthesia, incubators) is preferred, but strong R&D experience with active medical devices is also acceptable.

Benefits

• Competitive total reward package.
• Independent and varied job in an international environment.
• Flexible working hours.
• Ongoing training and development.
• A wide range of flexible benefits that you can tailor to suit your lifestyle.