Medical Device Software Specialist
3 ore fa
OverviewWe exist to create positive change for people and the planet.Join us and make a difference tooJob 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.Responsibilities & AccountabilitiesPlan 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, make certification recommendations for CE, UKCA and ISO ***** 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.QualificationsDegree 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).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 and awareness of current industry trends.What We OfferBSI 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, including an annual conference for continued professional development.About UsBSI is a business improvement and standards company and, for over a century, 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.Leveraging extensive expertise across sectors including automotive, aerospace, built environment, food and retail, and healthcare, BSI helps clients fulfil their goals.Our core values are Client-Centricity, Agility, and Collaboration, and we support organizations to grow by tackling society's critical issues—from climate change to building trust in digital transformation and beyond—to accelerate progress toward a better society and a sustainable world.BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.J-*****-LjbffrMedical Device Software Specialist • Rome, Italy#J-*****-Ljbffr
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