Technical Specialist- IVD (In Vitro Diagnostic)

BSI

11d•$119,400 - $140,000•Remote

About The Position

BSI is seeking R&D Scientists and Production Scientists to join our IVD Devices Team as a Technical Specialist and Scheme Manager for CE Marking clients. Specifically, we are seeking people with knowledge of the design and manufacture of IVD Molecular oncology and CDx. Our Technical Specialists are industry experts that are analytical, communicative, diligent, and always curious. If you are looking for a career change and want to make an impact on patient safety – this may be a great fit for you! This is a home-based position with some travel.

Requirements

Bachelor's degree or higher in a discipline relevant to IVD medical device design, manufacture and use, or equivalent qualification.
At least (4) years' post-graduate experience in the design and development of IVD medical devices, including the principles of design control, risk management and performance and/or clinical evaluation primarily focusing on IVD Molecular oncology and CDx
Knowledge of medical device regulations.
Awareness of certification business processes, the application of quality management standards, and audits

Responsibilities

Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise
Deliver technical reviews, scheme management in support of the CE marking schemes
Provide Medical Device QMS assessment and device expertise leadership and mentoring in areas of competence to Healthcare personnel
Provide “Technical Sales/Networking” support to the commercial team