Sahana Roop Kumar
San Jose,USA
Summary
Experienced quality professional specializing in global design control compliance for medical product development. Proven track record in leading quality initiatives and enhancing regulatory adherence for implantable, wearable, and digital health technologies.
Overview
11
11
years of professional experience
1
1
Certification
Work History
SOFTWARE QUALITY ENGINEER
Verily Life Sciences
San Bruno, California
06.2021 - Current
- Led the design transfer of Verily Retinal Service in collaboration with design engineers, hardware engineers, and manufacturing team that resulted in successful commercial launch.
- Quality representative supporting internal and external audits for a Class II medical device, and a SaMD.
- Supporting software and hardware development teams in the creation of Design History Files (DHFs), including development plans, verification and validation plans, requirements specifications, software architecture and design documents, Risk Management File (RMF), test protocols and reports, and traceability matrices. Supporting the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
- Guiding the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
- Leading risk-based design verification, and validation planning and execution, including any cross-functional investigation and resolution activities.
- Authoring risk management deliverables from product concept through commercialization.
- Led the implementation of cloud-native PLM, which helps streamline product development and ensures regulatory compliance.
- Co-authoring a letter to file with the FDA for hardware and software post-market changes for a Class II medical device.
- Supporting strategic relationships with internal cross-functional teams and contract manufacturing organizations (CMOs).
- Supporting the establishment of component specification definitions, supplying component sampling plan development, and vendor qualifications.
- Contributing to quality improvement initiatives and ensuring compliance with relevant regulations and standards.
REGULATORY TEAM MEMBER AND QUALITY ENGINEER
Profusa, Inc
Emeryville, California
01.2018 - 06.2021
- Second hire in the Quality group.
- Led global quality engineering activities in new product development, manufacturing, commercialization, and post-market surveillance.
- Successfully established effective auditing practices, reducing findings by over 80% from previous audits.
- Owned design history file(s) for products (wearable devices, SaMD), including verification, validation plans, product requirements specifications, Risk Management File (RMF), and traceability matrices.
- Risk management lead in the development of risk management program to support CE mark from planning to post-market surveillance in compliance with ISO 14971
- Built training systems to raise the importance of quality assurance in the path to commercialization.
- Participated in regulatory submissions by authoring and reviewing Technical Files, FDA annual reports, and FDA pre-market submissions (de novo 510(k)) for digital health solutions.
- Worked with Project Management, Information Technologies, and other cross-functional partners to continually improve ease of compliance for fast-moving project teams.
- Championed quality and compliance by performing external supplier and internal system audits to ensure regulatory and internal process requirements are met.
- Maintained effective quality metrics to proactively measure, monitor, and improve the quality system.
- Performed CAPA (Corrective Action Preventive Action) by providing technical expertise in root cause analysis and statistical techniques to identify solutions to a range of problems.
- Led design assessment and configuration management of a product, device, process performance, and internal/external customer expectations worldwide.
- Developed a quality improvement strategy in alignment with the business goals.
REGULATORY AFFAIRS INTERN
USC Regulatory Science Consulting Center
Los Angeles, California
09.2017 - 12.2017
- Led the regulatory affairs team of 10 to draft a Traditional 510(k) and an Abbreviated 510(k) for Class II devices.
- Authored a regulatory intelligence report for a Class II device, discussing requirements for clinical trials.
REGULATORY AFFAIRS INTERN
Verily Life Sciences
South San Francisco, California
05.2017 - 08.2017
- Implemented a medical device reporting system (eMDR) to achieve the FDA's post-marketing compliance.
- Authored a FDA pre-submission to discuss the regulatory strategy for mobile medical applications.
- Supported regulatory leadership to enable the development of a holistic diabetes care platform.
- Authored a white paper on social media promotional approaches from a regulatory perspective.
- Developed a global regulatory requirements framework for digital health, encompassing 29 countries.
RESEARCH AND QUALITY ENGINEER
Capere Surgical Systems
Singapore, Singapore
09.2014 - 07.2016
- Second hire in the engineering team.
- Implemented QMS (ISO 13485) from the ground up.
- Led risk management activities per ISO 14971, with cross-functional teams.
Education
Master of Science - Medical Product Quality
University of Southern California
U.S.AMaster of Science - Biomedical Engineering
Nanyang Technological University
SingaporeBachelor of Engineering - Biomedical Engineering
M.S. Ramaiah Institute of Technology
IndiaSkills
- Notified Body audits and FDA inspections
- Quality Management System (QMS)
- European Medical Device Regulations (MDR)
- New product launches
- Product Development
- Training and guiding design teams
- Quality Process Improvement
- ISO 13485
- IEC 62304
- IEC 82304
- IEC 62366
- ISO 14971
- Problem Solving
- Stakeholder Engagement
- Regulatory and quality compliance
Certification
- Medical Device Cybersecurity 101, AAMI
- BSI Certified - ISO 13485:2016, Auditor Refresher
- BSI Certified - ISO 13485: 2012, Lead Auditor training
- European Medical Device Regulation Training GMED North America
- Biocompatibility of Medical Devices Namsa
- Validation of Sterile Medical Device, Nelson Labs, LLC
- Technical Documentation under the EU Medical Device Directives, TUV Rheinland
- Achieving regulatory compliance for the design process of medical devices, TUV Rheinland
- Clinical trials with medical devices, USC School of Pharmacy
- Regulatory Aspects of Clinical trial design, USC School of Pharmacy
Publications
Intelligent Stethoscope, International Journal of Biomedical and Clinical Engineering, 06/01/14, http://bit.ly/32ClE3c
Timeline
SOFTWARE QUALITY ENGINEER
Verily Life Sciences
06.2021 - Current
REGULATORY TEAM MEMBER AND QUALITY ENGINEER
Profusa, Inc
01.2018 - 06.2021
REGULATORY AFFAIRS INTERN
USC Regulatory Science Consulting Center
09.2017 - 12.2017
REGULATORY AFFAIRS INTERN
Verily Life Sciences
05.2017 - 08.2017
RESEARCH AND QUALITY ENGINEER
Capere Surgical Systems
09.2014 - 07.2016
Master of Science - Medical Product Quality
University of Southern California
Master of Science - Biomedical Engineering
Nanyang Technological University
Bachelor of Engineering - Biomedical Engineering
M.S. Ramaiah Institute of Technology
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