Great that you're thinking about a career with BSI!
About the role:
BSI ensures patient safety while supporting timely market access for our clients Medical Device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands, is an accredited ISO 13485 Certification Body and is recognized in many global markets.
As a Technical Specialist & Scheme Manager within our Active Devices team you will build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise.
The Active Team are looking for medical device professionals who have experience with a variety of active device types (e.g. 2 or more product types).
An active medical device is defined in the MDR as “any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy.”
Desired areas of active medical device expertise include ablation devices, hearing aids, infusion pumps, ventilators, software devices, surgical robots, x-ray machines, body-worn sensors, heart-lung machines, patient monitors, radiation therapy, surgical lasers, and ultrasound devices.
This is a home-based position with up to 25% travel when COVID-19 restrictions lift.
Technical Specialist Responsibilities:
Review and evaluate medical device technical documentation in your areas of competence to assess compliance with MDD 93/42/EEC and MDR 2017/745
Project manage certification scheme management activities for a portfolio of medical device manufacturers, including making recommendations for the issue and maintenance of MDD and MDR certifications
Have a minimum of 5 years of design and development or research and development experience with a variety active medical device (e.g. more than 2 active device product types)
Bachelor’s degree (or higher) in a discipline relevant to medical device manufacture and use. This may include electro-mechanical, applied physics, electronic/electrical, or biomedical engineering.
Have experience in electro-medical device technical development or testing and an awareness of the requirements of IEC 60601 Third Edition and the risk management standard ISO 14971
Understand the principles of design control, risk management, audit and clinical evaluations
Have strong interpersonal communication skills
Be capable of prioritizing and executing individual workload
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is an Equal Opportunity Employer and we are committed to diversity.
To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.