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Job Title: Technical Specialist, Scheme Manager, Clinical Evaluation Specialist - SaMD

Reports to: Technical Team Manager

Location: Home Based – Global

We have exciting opportunities for medical device software specialists to join our Software team. You will have the opportunity to work with medical device manufacturers across the globe, from dynamic start-ups through to established large manufacturers. We are seeking engineers with SaMD (Software as a Medical device) in technical capacity which can include product design, development and/or testing.

Purpose of the position

To build, manage, develop, control and manage a portfolio of Medical Device CE marking schemes. To deliver technical documentation assessments in support of the CE marking schemes. To provide Medical Device expertise leadership and mentoring in areas of competence to Healthcare personnel.

Key Responsibilities & Accountabilities

Plan and deliver Technical File Assessments, Design Examinations and Unannounced Audits to support EC Certification.

Manage client projects, acting as their primary contact and after satisfactory assessment, to make certification recommendations for CE, UKCA and ISO 13485 certificate issue to ensure compliance with required certification, timely delivery of services and client satisfaction.

Act as technical support to the commercial team when required to support business development and marketing activities as it grows the customer base worldwide.

Perform unannounced visits to medical device manufacturers globally as a technical expert to check on compliance with certification.

Work with Line Manager and other team leaders as required to provide reviews within area of expertise.

Essential Criteria:

4 or more years of Software Medical Device experience in a technical capacity, preferably within product design, development and/ or testing.

Interpretation and applications of International and National standards for the design, development and regulation of software medical devices.

Understanding of Risk Management and FMEA of Software Medical Devices.

Broad technical understanding of medical devices. Understanding of companies operating in these spaces and current industry trends.

Qualifications:

Degree educated (Bachelor’s minimum or equivalent) relevant to medical device design, development, manufacture and use i.e. electro-mechanical, electronic/electrical, biomedical engineering, computer science, medical physics or similar

What we offer:

BSI offers a competitive salary, ample annual leave/paid time off, and other robust benefits depending on country. We invest strongly in the development of our experts, a highlight being an annual conference where our hundreds of experts come together for intensive and exciting continued professional development.

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Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.