Technical Specialist, Clinical Evaluation Specialist & Scheme Manager - SaMD

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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.

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 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.

• 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.

• 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

BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development. For the US, this role offers 20-days annual leave, bank holidays, medical, dental, vision, and life insurance, 401(K) with company contribution, short-term and long-term disability, maternal leave, paid parental leave, paid bereavement leave, learning and development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle.

As the salary differs per country according to various factors, if you reside in another country, you’ll be notified of the salary range by the recruiter.

We are proud to be the business improvement company for other organisations to become more sustainable and resilient and finally to inspire trust in their products, systems, services, and the world we live in.

Headquartered in London, BSI is the world’s first national standards organization with more than 100 years of experience. We are a global partner for 86,000 companies and organizations in over 193 countries, offering development, auditing, certification, and training…