Stephany Esa

About Stephany Esa

Provides input to development teams in the design of highly complex medical devices. Ensures that compliance to customer and regulatory requirements is demonstrated and helps to ensure successful transfer of the design to manufacturing. Responsible for accurate, independent evaluation of Design History File documentation and overall Quality System compliance. Responsible for developing the design verification master plan, test protocols and reports, test method validation, developing design validation testing protocols, and providing statistical evaluations as applicable.Experience with activities in accordance to ISO14971 and ISO13485 include:• Risk Management Plans and Reports• Failure Modes and Effects Analyses (FMEAs) for user, design, software, and process errors• Risk Benefit Analysis• Design Verification- Master Verification Plans and Reports, Test Method creation and Validation• Design Validation- Formative and Summative studies• Process Validation- Part qualification, Installation qualification (IQ), Operation Qualification (OQ), and Process Qualification (PQ)• Quality Systems- Internal Audits, CAPAs, NCRs, preparation for FDA audit for class device manufacturer• DHF gap analysis• Supplier qualification, supplier quality specifications, and inspection reports

Experience

1. Director of Design Assurance Engineering

   Veranex

   Apr 2024 — Present · Providence, RI, US

   Provides oversight, management, leadership, and input to product development teams in the design of highly complex medical devices. Leads the accurate, independent generation and evaluation of risk management, Design History File documentation and overall Quality System compliance. Ensures compliance to customer and regulatory requirements and assists with the successful transfer of the design to manufacturing.Experience with activities in accordance with ISO 14971:2019 and ISO 13485:2016 include:Quality Plans and AgreementsRisk Management Plans and Reports, including Benefit Risk AnalysisFailure Modes and Effects Analyses (FMEAs) for user, design, software, and process errorsDesign Verification- Master Verification Plans and Reports, Test Method creation and Validation, equipment qualificationDesign Validation, including Formative and Summative studiesProcess Validation- Part qualification, Installation qualification (IQ), Operation Qualification (OQ), and Process Qualification (PQ)Quality Systems- Internal and External Audits, CAPAs, NCRs, preparation for FDA audit for class device manufacturer, SOP review and editsDHF gap analysisSupplier qualification, supplier quality specifications, and inspection reportsPost Market Surveillance Activities - Root cause analysis, design changes, DHF updates

Education

• Brown University

  Master of Science - MS

• Worcester Polytechnic Institute

  Bachelor of Science - BS