Jinang Shah
Systems Engineer |Abbott |Duke University |
- Role
- System Engineer at Abbott
- Location
- Los Angeles, CA, US
- LinkedIn followers
- 500 followers
About Jinang Shah
Results-driven Systems Engineer with 5+ years of experience in full-lifecycle Verification and Validation (V&V) for Class medical devices, including Software as a Medical Device. Adept at translating clinical user needs into actionable Systems engineering requirements within FDA-regulated environments, and skilled at bridging cross-functional teams from design through release.
Experience
System Engineer
Oct 2023 — Present · CA, US
Conducted Gemba Walks at local clinics, directly engaging with patients and physicians to observe implanted cardiac monitor andpacemaker workfl ows, capturing feedback to identify areas for process improvement- Developed key documentation including System Test Plans, System Bench Test Reports, and Entry and Exit Review Reports- Reviewed and evaluated user needs, corresponding use cases, and resulting system requirements to ensure traceability and alignment- Revised and improved technical documents used by Tech Services, enhancing clarity and usability- Specialized in insertable cardiac monitors, focusing on implant workfl ows and clinical workfl ow testing- Identifi ed and logged 48+ defects across System and Unit testing levels- Analyzed system requirements to design test edge cases- Collaborated with off shore development and testing teams to investigate system issues and drive resolution- Communicated daily project status updates to stakeholders, proactively identifying and addressing issues to minimize impact ontimelines.
Education
Duke University Pratt School of Engineering
Master of Science - MS, Bioengineering and Biomedical Engineering
Dwarkadas J. Sanghvi College of Engineering
Bachelor of Engineering - BE, Biomedical/Medical Engineering
2014 — 2018
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