BSI Group

Active Implantable Medical Device (AIMD) - Technical Specialist

US-CA-Los Angeles
Category
Healthcare
Contract Type
Perm Full-Time
Salary
Competitive Salary

About the Role

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.  The job holder will work in either our Milton Keynes office or a home based role. In addition to the UK we would consider applicants based in the USA or Europe.

 

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.

 

Expectations

  • Deliver AIMD, Medical Device and R&TTE CE Technical Assessment services either from the office or on-site as a fully integrated member of the AIMD Team
  • Perform Unannounced visits to manufacturers globally as a technical expert
  • Work with Line Manager and other team leaders as required to provide reviews within area of expertise
  • Deliver all services within required timescales and to a high quality
  • Maintain client satisfaction whilst continuing to meet BSI’s ethical expectations
  • Perform in-house and external training to colleagues and clients
  • Maintain competence in their area of technical expertise and AIMD, Medical Devices and R&TTE 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.

About You

To be successful in this role you will be educated with a BSc degree or PhD 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:

  • Neuro stimulators
  • Pace makers 
  • Implantable cardioverter-defibrillator (ICD)
  • Stimulation leads
  • Infusion pumps
  • Ventricular assist devices (VAD, LVAD)
  • Artificial hearts
  • Brachytherapy seeds and delivery systems
  • Cochlear implants 
  • Implantable sensors 
  • Medical Micro Electro Mechanical Systems (MEMS)

You will be able to demonstrate:

  • A broad technical understanding of Active Implantable Medical Devices. 
  • An understanding of companies operating in these spaces and current industry trends.
  • Hands-on experience of design, manufacture or testing in the AIMD industry, or clinical application of active implantable devices.
  • An appreciation of risks related to implanted materials.
  • An appreciation of risks related to use of software in critical applications.
  • An understanding of Risk Management and FMEA for active implantable devices.
  • Knowledge of Medical Device regulations and QMS systems for medical devices.
  • Interpretation and applications of International and National standards for the design, manufacture and regulation of medical devices.
  • Conceptual and analytical thinking, efficiency and results orientation.
  • Ability to work independently with minimal supervision; self-motivated.
  • Being a team player good at relationship building internally and externally.

About BSI

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.

 

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