Infosys
Medical Devices SME
Job Description
Responsibilities: • At least 15+ years of overall product development experience • At least 10+ years' experience working on software design and development of medical devices or Digital Health platforms. Candidates with additional experience in electrical hardware or embedded software will be preferred. • Proven track record of success in leading high-performing teams for developing and launching new medical devices and health platforms • Experience in working across entire lifecycle of medical device development covering documentation creation, participation in reviews across all phases of lifecycle using applicable QMS • Understanding of medical device regulatory standards like ISO 13485, IEC 62034, 21 CFR Part 820 and EU MDR regulations • Understanding of medical domains like Cardiac, Radiology, or any other • Experience in responding to RFPs with right technical solutions, estimates for completion and presenting the same to the clients • Good written and verbal communication skills. Educational Requirements MCA,MSc,Master Of Engineering,MTech,BSc,BCA,BTech,Bachelor of Engineering Additional Responsibities: None Technical and Professional Requirements: None
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