Nikita Joshi
@nikitajoshi1
Principal Design Quality Engineer driving compliant risk management and product reliability in medical devices.
United StatesWhat I'm looking for
I am a Principal Design Quality Engineer with 7+ years of experience delivering risk-based, compliant solutions for medical devices across cardiothoracic, orthopedic, wound care, and monitoring product families.
I lead risk management (plans, hazard analysis, FMEAs, reports) and serve as a Risk Management SME for NPI and sustaining projects, ensuring alignment with ISO 14971, EU MDR, and FDA QSR.
I have driven remediation of 50+ Risk Management Files in under two months, supported internal and external audits, and owned CAPA efforts to close root causes and improve product reliability.
I collaborate closely with cross-functional teams and clinical KOLs on verification, validation, usability testing, and post-market surveillance to maintain audit readiness and regulatory compliance.
Experience
Work history, roles, and key accomplishments
Principal Design Quality Engineer
Cardinal Health
Jan 2023 - Present (3 years 1 month)
Lead risk management and compliance for cardiothoracic, women’s health, wound care, and cardiac monitoring product families; remediated 50+ Risk Management Files in under 2 months and supported audits and CAPA closure to improve product reliability and audit readiness.
Design & Reliability Quality Assurance Engineer II
Smith & Nephew
Jan 2021 - Dec 2022 (1 year 11 months)
Managed risk management, usability, and biocompatibility for Class II/III orthopedic products; led design validations with surgeons/KOLs and improved EU MDR compliance through risk log remediation and CAPA management.
Design & Reliability Quality Assurance Engineer II
Integra LifeSciences
Oct 2018 - Dec 2020 (2 years 2 months)
Supported NPI quality for orthopedic and tissue technology devices through launch and post-market, leading risk management, verification/validation testing, and maintaining compliance with ISO and EU MDR standards.
New Product Development Co-op
Invacare Corporation
Aug 2017 - Sep 2018 (1 year 1 month)
Rotated across R&D, respiratory, and product management teams to perform V&V testing and statistical analysis; improved first-pass yield by 20% and contributed to 510(k) documentation and audit support.
Education
Degrees, certifications, and relevant coursework
Cleveland State University
Master of Science, Biomedical Engineering
Master of Science in Biomedical Engineering (Design Track); achieved Dean's List recognition.
Youngstown State University
Bachelor of Science, Biological Sciences
Bachelor of Science in Biological Sciences with a minor in Chemistry.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
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