Technical Reviewer Active Medical Devices

Technical Specialist & Scheme Manager - Active Devices

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 lifecycle to place active medical devices on the European market. This position requires a mix of engineering and design knowledge, regulatory expertise, English writing skills, and client and project management capabilities. You will assess cutting-edge technology that will improve 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 determining auditing requirements and making recommendations for the issuance 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.

To Be Successful In This Role, You Will Have

• A minimum of 5 years of design and development, 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. This may include electronic/electrical, electro-mechanical, or biomedical engineering or medical physics.
• Current focus on R&D experience across: Respiratory devices (e.g., ventilators), Anaesthesia, or Incubators; however, strong R&D experience with other active medical devices is also valued.
• Thorough knowledge of Medical Device regulations; 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.

BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development, and a wide range of flexible benefits. We are the business improvement company, inspiring trust in products, systems, services, and the world.

Headquartered in London, BSI is the world's first national standards organization. We partner with 86,000 companies in over 193 countries, offering development, auditing, certification, and training services.

BSI is committed to ensuring the diversity of our workforce reflects that of our clients and communities. We aim to create a sense of belonging for all employees.

Key skills/competency

• Technical Reviewer
• Active Medical Devices
• Medical Device Regulation
• MDR 2017/745
• MDD 93/42/EEC
• IEC 60601
• ISO 14971
• Risk Management
• Design Control
• R&D Engineering