Sahana Roopkumar
Software Quality Engineer at Verily Life Sciences- Claim this Profile
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English -
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Bio
Credentials
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EU Medical Device Regulation EU MDR 2017/745
GMEDMar, 2019- Nov, 2024 -
Clinical trias in special populations
University of Southern CaliforniaMar, 2017- Nov, 2024 -
Validation of sterile medical devices
Nelson Laboratories, LLCNov, 2015- Nov, 2024 -
Technical documentation under the EU Medical Device Directives
TUV Rheinland SingaporeJul, 2015- Nov, 2024 -
Regulatory compliance for design process of medical devices
TUV Rheinland SingaporeMar, 2015- Nov, 2024 -
EN ISO 13485:2012 Lead Auditor
BSI
Experience
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Verily
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United States
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Hospitals and Health Care
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700 & Above Employee
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Software Quality Engineer
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Jul 2021 - Present
Participating in ongoing implementation of Software Quality Management System by integrating internal and external medical device best practices Supporting integration of ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC Guiding software teams in design controls and risk management activities Fostering organizational compliance to the quality system Participating in ongoing implementation of Software Quality Management System by integrating internal and external medical device best practices Supporting integration of ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC Guiding software teams in design controls and risk management activities Fostering organizational compliance to the quality system
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Profusa
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Quality Engineer
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Jan 2018 - Jul 2021
Lead global quality engineering activities in new product development, manufacturing, commercialization, and support. Successfully led design transfer efforts for a wearable device with contract manufacturer ensuring a smooth transfer of production and process requirements to manufacturing and maintaining reliable, high-quality supply of a product. Design assurance lead owning design history file(s) for products (SaMD) including verification, and validation plans, product requirements specifications, Risk Management File (RMF), and traceability matrices. Risk Management Coordinator performing risk evaluation and associated risk management activities including FMEA, product risk analysis, and mitigation of product issues. Driving process development and manufacturing operations for implantables in equipment development, process development, IQ, OQ, PQ work, and activities such as pFMEA, test method validation and non-conformance containment and disposition. Managed production center quality controls within Class 8 Cleanroom and implemented processes including incoming, in-process and final acceptance metrics Led supplier and internal audit program to implement continuous quality improvement efforts. Developed and maintained effective Quality Metrics to proactively measure, monitor and improve the Quality System Participated in technical and management reviews to ensure design plans, product design, and deliverables related to the product are met. Worked as an individual contributor and providing guidance to cross-functional team members. Show less
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USC Regulatory Science Consulting Center
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University of Southern California
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Regulatory Affairs Intern
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Jan 2017 - Jan 2018
Developed a regulatory strategy for a combination product by analyzing data from multiple sources and generated risks. Prepared 510(k)s to obtain regulatory clearances for new products, new indications, and significant product changes. Reviewed 510 (k) of a predicate device to develop a comparison between the new device and the predicate device in terms of technical characteristics. Conducted risk-benefit analysis by consolidating clinical and non-clinical data. Communicated regulatory requirements and the impact of regulations to ensure compliance. Supported creation of CE/Combination product Technical Files/Dossier. Authored a white paper on UDI requirements for class I, class II and class III devices. Medical device reimbursement strategy Compiled the list of the codes of the product, including the CPT codes, the HCPCS codes, and ICD-10-CM code. Determined the Medicare payment rate for each service, procedure, and product. Identified and collected National Coverage Determinations and Local Coverage Determinations pertinent to the product. Clinical trial monitoring Collaborated with the team to conduct a site initiation visit as a part of a clinical trial site selection process. Reviewed complex reports and protocols for scientific merit and regulatory appropriateness. Worked closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for research studies are up-to-date. Show less
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Verily
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United States
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Hospitals and Health Care
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700 & Above Employee
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Regulatory Affairs Intern for Verily at Google
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May 2017 - Aug 2017
Contributed to software medical device development by actively being engaged with the team that emphasis on regulatory strategy development through the following: Implemented an eMDR (Medical Device Reporting) system to achieve FDA’s required post-marketing compliance objectives. Lead FDA pre-submission for software-driven medical devices. Authored a white paper on Social Media Advertising and Promotional approaches from a regulatory perspective for medical devices. Developed global regulatory requirements framework for medical devices including 29 countries. Created awareness within the organization regarding international and domestic regulations and product-specific standards. Supported continuous improvement efforts of the submission process. Show less
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Capere Surgical Systems Pte Ltd
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Singapore
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Quality and Research Engineer
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Jul 2014 - Jul 2016
Worked for a Singapore based Med-tech start-up company dealing with design and development of novel solutions to address unmet clinical needs, in the field of orthopedic and extremities surgery. Second hire in the engineering team Established and implemented of the quality management system according to ISO 13485. Provided engineering best practices and continuous improvement initiatives to reduce scrap, repairs, and process waste. Participated in risk analysis activities including but not limited to Failure Modes and Effects Analysis, and health hazard assessments. Performed feasibility testing, statistical data analysis, sample size determination, and supplier qualifications. Provided direction in developing inspection plans, sampling plans, inspection& acceptance criteria and design verification and design validation testing. Show less
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Fisher & Paykel Healthcare
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New Zealand
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Medical Equipment Manufacturing
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700 & Above Employee
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Summer Intern
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May 2011 - Jul 2011
Broadened my theoretical knowledge by closely understanding the design, application and field verification and validation of Respiratory devices namely Humidifiers, CPAP(continuous positive airway pressure) machine and Bubble CPAP. Collaborated with the company to document clinical and technical aspects of these devices. Broadened my theoretical knowledge by closely understanding the design, application and field verification and validation of Respiratory devices namely Humidifiers, CPAP(continuous positive airway pressure) machine and Bubble CPAP. Collaborated with the company to document clinical and technical aspects of these devices.
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Education
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2016 - 2018
University of Southern California
Master's degree, Medical Product Quality -
2013 - 2014
Nanyang Technological University
Master of Science (M.Sc.), Biomedical/Medical Engineering -
2008 - 2012
M.S. Ramaiah Institute Of Technology
Bachelor of Engineering (B.E.), Biomedical/Medical Engineering
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