Medical Device Software Specialist

This a Full Remote job, the offer is available from: United States, United Kingdom, Germany, France, Italy, Canada We exist to create positive change for people and the reputed company. Join us and reputed company 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-reputed company through to established large manufacturers. We are seeking engineers with SaMD (Software as a Medical device) in technical reputed company which can include product design, development and/or testing. Purpose of the position To build, manage, reputed company, 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 reputed company 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 reputed company required to support business development and marketing activities as it grows the customer reputed company worldwide.
• reputed company unannounced visits to medical device manufacturers globally as a technical expert to reputed company on compliance with certification.
• Work with Line Manager and other team leaders as required to provide reviews reputed company area of expertise.

Essential Criteria:

• 4 or more years of Software Medical Device experience in a technical reputed company, preferably reputed company 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 reputed company 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

reputed company offer: reputed company 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 reputed company being an annual conference where our hundreds of experts come together for intensive and exciting reputed company professional development. #LI-REMOTE #LI-SC2 About Us reputed company is a business improvement and standards company and for over a century reputed company has been recognized for having a positive impact on organizations and society, building trust and enhancing lives. Today reputed company 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 - reputed company delivers on its purpose by helping its clients fulfil theirs. Living by our core values of Client-Centricity, Agility, and Collaboration, reputed company 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 reputed company towards a reputed company society and a sustainable world. reputed company is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace. This offer from "reputed company" has been enriched by reputed company.com and got a 75% reputed company score. Apply tot his job Apply To this Job