Venkata Kanaparthi
Medical Device Quality Engineer | Expertise in 510K, PMA, New Product Development, Risk Management, Process Validation and PMS | ISO 13485, FDA QSR, and ISO 14971 Compliant | Enhancing Quality & Safety in Medical Devices
- Role
- Npd R & d Engineer at Johnson & Johnson
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
About Venkata Kanaparthi
As a seasoned Medical Device Quality Engineer with more than seven years of industry…
Experience
Npd R & d Engineer
Sep 2024 — Present · Plymouth, MN, US
Collaborating with cross functional teams, including R&D, Design Quality, Regulatory and Manufacturing to support the development and commercialization of reprocessed devices.• Spearheaded comprehensive risk assessments and gap analyses for medical devices in strict accordance with ISO 14971:2019, ensuring all potential hazards were identified and mitigated.• Conducted detailed Risk Benefit Analysis (RBA) to balance product efficacy with patient safety, leveraging statistical tools and methodologies (SPC, DFMEA) to support data-driven decisions.• Developed and maintained robust Risk Management Files (RMF), integrating detailed risk assessments and control measures to meet FDA, EU MDR, and ISO compliance standards.• Work in synergy with quality assurance and regulatory teams to identify critical hazards and ensure compliance with industry standards, such as ISO 14971 and ISO 13485.
Education
Lamar University
Master's degree
2017 — 2019
Andhra University College of Engineering
Master of Science - MS
2010 — 2015
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.