Denise Wagner

Principal Consultant & Sr. Director HF/UE

Country

United States

City

Winona Lake

Industry

Medical Device

Skill

Human Factors Engineering, Design Validation, Design Control, Risk Analysis, Technical Training, Medical Devices, Lean Process Improvement, Ergonomics, Ethnographic Research, Use Error Analysis, Organization Development, NPD Staged Gate Processes & Procedures, Ethnography, Minitab, CAPA, V&V, Quality System, Validation, FDA, ISO

Experience

Principal Consultant & Sr. Director HF/UE

Agilis Consulting Group

2022-7 - 2023-8 · 1 yr 2 mos

Warsaw, Indiana, United States

At Agilis Consulting I help clients optimize their risk management, usability & design control analyses and testing so that we can bring safe and effective solutions to health care professionals and patients.

Member

AAMI Human Factors Engineering Committee

2016-1 - 2023-8 · 7 yrs 8 mos

Senior Manager Systems Engineering, Orthopedic Robotics

Johnson & Johnson

2018-7 - 2022-6 · 4 yrs

Warsaw, Indiana, United States

Led the global multi-site orthopedic robotics systems engineering team in performing system requirements & risk analyses, usability engineering, system integration, and all system verification & validation testing.

Senior Principal Human Factors Engineer

Johnson & Johnson MedTech

2015-11 - 2018-7 · 2 yrs 9 mos

Warsaw, Indiana

Human Factors Engineering & Quality Systems Consultant

HFE & QS Consulting LLC

2013-5 - 2015-11 · 2 yrs 7 mos

Angola, Indiana

Conducted use risk and user needs analysis to determine usability requirements and design solutions. Planned, executed and documented formative, summative and design validation studies. Created and implemented Usability Engineering, Design Control and Risk Management processes and procedures. Designed and delivered usability engineering training. Compiled HFE/UE Reports for FDA submissions, Special 510Ks, Traditional 510Ks, Clinical Evaluation Reports and Tech File Updates.