We exist to create positive change for people and the planet. Join us and make a difference too! 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. #LI-REMOTE #LI-SC2 About Us 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. Not found an opportunity of interest currently listed? Introduce yourself to the BSI TA team, set up personalized jobs alerts and easily apply for future opportunities. At BSI, we exist to have a positive impact. Our people influence international thinking and action on important issues. Their work builds trust in businesses and communities and enhances lives. Now we’re looking for passionate people to help us take on society’s biggest challenges. You’ll partner with key stakeholders to accelerate progress towards a better society and a sustainable world. Together, we’ll create solutions to global challenges like the climate crisis and how AI will be used. You’ll do rewarding, purpose-led work that impacts people’s health, safety and wellbeing. Your integrity will earn the trust of our stakeholders as we raise awareness of the difference we make to people around the world. You’ll have the opportunity to work across a wide range of industries across the globe. Are you looking to grow your career in an organization that supports your development and performance? You can be your best self, do your best work and make a difference here, because life at BSI is #NotYourStandardCareer. Be part of our future.
