Senior IVD Medical Device Technical Specialist - Remote

BSI; United States; Remote; USD 90,000 - 134,000; Full time

Job summary

BSI is seeking a Technical Specialist for IVD devices to lead CE marking schemes and provide technical reviews and QMS guidance from a home-based position with travel. The role emphasizes design control, risk management, and regulatory knowledge for infectious disease devices.

The ideal candidate holds a degree in an IVD-related field and has 4+ years of post-graduate experience in design and development of IVD medical devices, including clinical evaluation activities and awareness of regulatory

Qualifications

• 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 infectious diseases.
• Knowledge of medical device regulations and awareness of certification business processes, 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

Skills

Analytical thinking

Strong communication

Detail oriented

Education

Bachelor’s degree in IVD-related field

Job description

BSI is seeking a Technical Specialist for IVD devices to lead CE marking schemes and provide technical reviews and QMS guidance from a home-based position with travel. The role emphasizes design control, risk management, and regulatory knowledge for infectious disease devices.

The ideal candidate holds a degree in an IVD-related field and has 4+ years of post-graduate experience in design and development of IVD medical devices, including clinical evaluation activities and awareness of regulatory