Great that you're thinking about a career with BSI!
Job Title: Technical Specialist and Scheme Manager - AIMD
Reports to: Technical Team Manager
Rental: Global Homebased
We have exciting opportunities for Medical Device professionals who have Active Implantable Medical Devices experience to join our global team.
You will have the opportunity to work with medical device manufacturers across the globe, from dynamic start-ups through to established large manufacturers.
As a dedicated Technical Specialist you will be responsible for reviewing the design dossiers of a wide range of Active Implantable Medical devices with the aim of determining whether or not the devices meet the requirements of the Medical Device Regulation and relevant harmonized standards.
Key Responsibilities & Accountabilities:
- Carrying out detailed assessments of design and manufacturing data to ensure that Active Implantable Medical Devices meet the safety and performance requirements of the regulations
- Compiling Technical Evaluation Assessment Reports (TEAR's)
- Working with Clinical Evaluation Specialists to determine the clinical impact of design changes and determining the level of clinical / technical assessment required
- Working with Scheme Managers to ensure that certification schemes are being appropriately maintained
- Leading client meetings to facilitate the CE marking processes
Education and qualifications:
Successful completion of a university or a technical college degree or equivalent qualification in relevant studies, such as, bio-medical, systems, mechanical, electronics or software engineering or other relevant sciences.
- Proven experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research.
- This experience should include the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.
Ideally, you would have knowledge and experience in the design, manufacturing and use of one or more of the following
Active Implantable Medical Devices:
- Implantable cardioverter-defibrillator (ICD)
- Infusion pumps
- Ventricular assist devices (VAD, LVAD)
- artificial hearts
- Brachytherapy seeds and delivery systems
- Implantable sensors
Medical Micro Electro Mechanical Systems (MEMS)
What we offer:
- BSI offers a competitive salary, ample annual leave / paid time off, and other robust benefits depending on country.
- We invest strongly in the development of our experts, a highlight being an annual conference where our hundreds of experts come together for intensive and exciting continued professional development.
- Our Excellence Behaviors: Client-centric, Agile, Collaborative.
- These three behaviors 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.