Joyce Lefevre

About Joyce Lefevre

As a Sr. Manager, SRC R&D Embedded Software Test Engineering at Philips Healthcare, I…

Experience

1. Sr Manager, Src R & d Global Software Test Engineering

   Philips

   Feb 2008 — Present · Pittsburgh, PA, US

   Excellent Project & People Management Skills - leading large teams of testers / technicians and facilitating communication and collaboration across the engineering / quality groups. Managing the team through a challenging time of transition.• Led V&V of new and modified products against requirements/use cases• Close Collaboration with Regulatory Team – develop testing inputs for 510(k) – Bench / SW Testing. Led multiple FDA Additional Information Request responses related to NPD • Organized & Led Mock Audit Sessions and Audit Readiness Sessions with the Global Compliance Team for projects across SRCProject Summary:Systems Lead for Alice PDx - 2008.Overall V&V / Test Engineering lead for the following products: Alice 6 (sleep diagnostic system)- 2011; DreamStation (CPAP/Bi-PAP/Auto)- 2015.DreamStation Go (CPAP/Auto CPAP)- 2017.E30 (Covid-19 response Ventilator - EUA release)- 2020DreamStation 2 - 2021Promoted to Group Leader - 2022Participated in all phases of QA including:• Facilitate requirements architecture and analysis• Creating test strategy, plan, budget and schedules to contribute to overall project planning• Developing tests; executing test cases, documenting and evaluating results• Experience in various types of testing: o HW / embedded FW testing o PC Application SW testing o Manual Testing o Regression Analysis / Testing• Provide testing metrics to track progress. • Reporting: consolidate and report test results to relevant stakeholders and formal reports.• Post Market: Analyzing field issues / root cause analysis to improve coverage of existing test suites and to eliminate future occurrences of similar defects. • Effectively communicate problems and solutions within the team and organization, including recommendations for actions and process improvement ideas.2015 - Speaker & Panelist at Q1 Productions, 2nd Annual Medical Device Verification & Validation Conference in Alexandria, VA.

Education

• Missouri University of Science and Technology

  Bachelor of Science (B.S.), Electrical Engineering

  1997 — 2000

• Case Western Reserve University

  Biomedical/Medical Engineering and Electrical Engineering

  1995 — 1997

Skills

• Quality System
• V&V
• Data Analysis
• Product Launch
• Minitab
• Testing
• Iso 13485
• Design Control
• Labview
• Automation
• Fmea
• Fda
• Manufacturing
• Research and Development (R&D)
• Iso 14971
• Medical Devices
• Capa
• Validation
• R&D
• U.s. Food and Drug Administration (Fda)
• Embedded Systems
• Quality Assurance