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

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.

About BSI

BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives. Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments. Utilizing its extensive expertise in key industry sectors – including automotive, aerospace, built environment, food and retail, and healthcare – BSI delivers on its purpose by helping its clients fulfil theirs. Living by our core values of Client‑Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between – to accelerate progress towards a better society and a sustainable world. BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.