Medical Device Software Specialist

Medical Device Software Specialist at BSI

We exist to create positive change for people and the planet. Join us and make a difference too!

Purpose of the Position

As a Medical Device Software Specialist, you will be instrumental in building, managing, developing, controlling, and overseeing a portfolio of Medical Device CE marking schemes. This role involves delivering comprehensive technical documentation assessments crucial for CE marking and providing expert leadership and mentorship in your 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, making certification recommendations for CE, UKCA, and ISO 13485 certificate issuance to ensure compliance, timely service delivery, and client satisfaction.
• Act as technical support to the commercial team when required, supporting business development and marketing activities to grow 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 your 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 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.
• 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, such as 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 the country. We invest strongly in the development of our experts, highlighted by an annual conference where hundreds of experts gather for intensive and exciting continued professional development.

Key skills/competency

• SaMD (Software as a Medical Device)
• Medical Device Software Development
• Regulatory Compliance
• CE Marking
• UKCA Certification
• ISO 13485
• Risk Management (ISO 14971)
• FMEA
• Technical Documentation Assessment
• International Standards Application