We currently have an exciting opportunity in our Medical Devices Notified Body working as a Technical Specialist within the Active Implantable Medical Devices (AIMD) Team. This is a homebased role that can be located anywhere in the US with 25-50% travel.
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 the devices meet the requirements of the Active Implantable Medical Devices Directive and relevant harmonised standards. You will write comprehensive audit reports which either support or reject the manufacturers application for CE marking based on the evidence provided. Ultimately your work will determine whether or not a device has been demonstrated to be safe and effective, meets its intended use and can be awarded CE certification.
Strong project management skills are essential as you will manage your own work load, be responsible for ensuring that reviews are delivered within agreed timescales and that your time is booked and charged appropriately.
Strong inter-personal communication skills are at the heart of this role as you work on a daily basis with manufacturers as they plan and execute their conformity assessment projects. You will regularly lead technical discussions with manufacturers and will be able to interpret regulatory requirements, pose relevant technical questions and clearly communicate areas of non-conformity.
To be successful in this role you will be educated with a Bachelor of Science degree in a discipline relevant to AIMD design and manufacture, or equivalent qualification and have a minimum of 10 years’ experience in the design and development of one or more of the following implantable medical devices:
You will be able to demonstrate:
Our ambition is to be recognized and valued globally as a best-in-class company; a client-driven, efficiently-run, growing business. BSI has come a long way since being founded in 1901. Today, we're a global business services organization, respected world over for the development of standards; assessment of management systems; testing and certification of products and services; providing software solutions; and the delivery of training courses. We offer diverse career paths from auditing to sales, product development to finance, and from IT to marketing.
With around 4,000 employees working with over 80,000 clients in 172 countries it means that career opportunities are vast. BSI challenges mediocrity and complacency to help embed excellence into the way people and products work. That means showing businesses how to improve performance, reduce risk and achieve sustainable growth.
Our Vision: "To be the global business improvement partner of choice.”
Our Mission: "To help organizations embed excellence", and states our shared purpose.
Our Values: "Integrity - Continual improvement - Inclusivity", guide us in the way we work and help us deliver our Vision and Mission.
What we offer:
BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.
BSI is an Equal Opportunity Employer and we are committed to diversity.