BSI
Great that you’re thinking about a career with BSI!
BSI is seeking experienced R&D or Test Engineers to join our Active Devices team as a home-based Technical Specialist & Scheme Manager.
As a Technical Specialist & Scheme Manager, 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.
We are looking for medical device professionals with experience with a variety of active device types. Desired areas of expertise include medical software development, artificial intelligence, machine learning, infusion pumps, ventilators, aesthesia equipment, ablation devices, hearing aids, surgical robots, imaging devices, body-worn sensors, heart-lung machines, patient monitors, surgical lasers, sterilizers, and ultrasound devices.
Technical Specialist 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 EC certifications.
Education/Qualifications
- A minimum of 5 years of design and development or research and development or testing experience with a variety of active medical device (e.g. more than 2 active device product types)
- Ideally experience working with Artificial Intelligence
- 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
- Understand the principles of design control and risk management
- Have strong interpersonal communication skills
- Be capable of prioritizing and executing individual workload
This is a home-based position located in Europe, the US or Canada, with up to 20% travel when COVID-19 restrictions lift.
What We Offer
BSI offers a competitive salary, ample annual leave/paid time off, and other robust benefits depending on country.
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 conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
To apply for this job please visit wd3.myworkdaysite.com.