Medical Device Software Specialist

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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 work with medical device manufacturers across the globe, from dynamic start‑ups through to established large manufacturers.

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.

• Plan and deliver Technical File Assessments, Design Examinations and Unannounced Audits to support EC Certification.
• Manage client projects, acting as their primary contact and, upon successful assessment, recommend certification for CE, UKCA and ISO 13485 to ensure compliance and timely delivery of services and client satisfaction.
• Act as technical support to the commercial team when required to support business development and marketing activities.
• Perform unannounced visits to medical device manufacturers globally as a technical expert to check compliance with certification.
• Work with Line Manager and other team leaders as required to provide reviews within area of expertise.

• 4 or more years of Software Medical Device experience in a technical capacity, preferably within product design, development and/or testing.
• Interpretation and application 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 and current industry trends.

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

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, with an annual conference where our hundreds of experts come together for intensive and exciting continued professional development.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.