BSI Group

Medical Device Technical Specialist - IVD

BSI Group
United States
12 Oct 2019
11 Nov 2019
Full Time
Contract Type
Experience Level
Experienced (non-manager)
About the Role

Do you have experience within the medical field? Have you worked with in vitro diagnostic (IVD) medical devices previously? Would you like to work with cutting edge innovation and state of the art technologies?

Due to continuing strategic growth within our Medical Devices business, we currently have vacancies for Technical Specialists within the IVD Devices team coming up in 2020. This is an excellent opportunity to join a leading Notified Body, driving up the standard of safety and performance of Medical Devices for patients globally, and to be involved in the evaluation of cutting edge innovation and state of the art technologies. Strong interpersonal communication and project management 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.

Job Duties:
  • Build control, and manage a portfolio of Medical Device CE marking schemes focused around your area of IVD expertise.
  • Review and evaluate medical device technical documentation and project management
  • Provide Medical Device QMS assessment, device expertise, and mentoring colleagues in your area of competence

This homebased position is full-time, salaried, and involves up to 25% travel by car and plane for client meetings, trainings, and team meetings.

Medical Devices | Technical Specialist | Active Devices | Quality Management | Research | Design | Development | R&D | Research and Development

About You

The Technical Specialist role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria.

Job Requirements:
  • Bachelor's degree (or higher) in a discipline relevant to medical device manufacture and use
  • Thorough knowledge and at least five (5) years of experience in the design, development, manufacture or testing (use) of In Vitro Diagnostics (IVDs).
  • Thorough knowledge of Medical Device regulations, ISO 13485 and have a broad technical understanding of the medical device industry.
  • Excellent written and verbal English communication skills
  • Ability to travel 25% for trainings, team meetings, and client visits

In addition, you will:
  • Have a conceptual and analytical way of thinking, be efficient and results orientated
  • Be a team player good at relationship building internally and externally

About BSI

BSI (British Standards Institution) has over 81,000 clients in 180 countries, and is an organization whose standards inspire excellence across the globe. BSI Medical Devices Notified Body provides rigorous CE and ISO 13485 certification to manufacturers globally. The team apply their knowledge to 3rd party conformity assessment of all types of medical devices; active devices, active implantable devices, in vitro diagnostic devices, orthopaedic and dental devices, vascular devices, wound care devices and many others. The team has doubled in size over the past eight years, demonstrating the company's desire to succeed and deliver world beating results. There are exciting opportunities for further growth of the Medical Devices team.

What We Offer:
  • Competitive base salary plus 10% annual bonus
  • Generous paid time off and paid holidays
  • 401k with employer match
  • Medical, Dental, Vision, and Life Insurance plus Short and Long-term Disability Coverage

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