About

Abhinav Mehra is a highly skilled Sr. Systems Engineer with over 6 years of relevant experience in the medical device industry. Currently, he works at Alphatec Spine, AlphaInformatix as a Sr. Systems Engineer, where he is responsible for leading the transition to a new requirements management tool with integration in Azure DevOps (AZDO) from DOORS using in-house developers and third parties. He is also integrating test evidence and anomaly tracking management systems to develop traceability from requirements/test evidence/anomaly fixes. Previously, Abhinav worked as a Sr. Systems Engineer at BD, where he was recognized as a top 15% performer and received multiple incentives for leading SE team in 483 remediation, 510(k)/Emergency Use Authorization (EUA)/Certificate of Medical Necessity (CMN) releases. He was the SE lead for infusion pump embedded and PC app software development, and he was a cross-functional team member in performing risk analyses, design reviews, requirement updates, assessing V&V strategies, and generating trace matrices for UN → V&V traceability. Abhinav was also the SE lead in developing new software risk analysis to comply with ISO 14971 and IEC 62304:2015 for 510(k) submission (risk and safety assurance case deliverables). He worked with the SWE team to create compliant SW fault tree analysis/FMEA for an existing product in the market for over 20+ years. He successfully identified critical components of the system and developed requirements as control measures to drive verification testing and ensure risks are fully mitigated. Abhinav also worked as a Systems Engineer II at Leica Biosystems, where he led the systems engineering team (HW & SW) in CE-IVDD registration for a new product launch. He created and organized documentation from the design input phase to design V&V and visited end-users during beta validation testing to understand VOC and assist in improving lab workflow and efficiency. Abhinav was trained in problem-solving process (PSP), daily management (DM), and visual project management (VPM) and implemented all processes in everyday work. He also assisted in CDT&R for new and existing products to improve customer reliability and understand and bucket unknown failure modes. Abhinav has a Bachelor of Science (BS) in Biomedical/Medical Engineering from Georgia Institute of Technology. He is proficient in test, software engineering, DevOps, Azure, and integration.