Johnson & Johnson MedTech

Overview

As a Human Factors Engineering Co-op at Johnson & Johnson MedTech, I was embedded in one of the world's leading medical device organizations working on surgical instruments. Alongside senior human factors engineers, I gained hands-on experience with the full spectrum of HF activities—from task analysis and risk assessment to cross-functional collaboration with regulatory, clinical, and design teams.

This wasn't a typical internship of shadowing. I was trusted with real responsibilities on real medical device programs, applying methods like PCA analysis and FMEA to identify critical use errors before they could impact patient safety.

The Challenge

The project focused on a surgical device with an innovative feature. The challenge was to identify critical tasks and potential use errors associated with the new feature—particularly for users who might be unfamiliar with it. The device was used by multiple user groups in the surgical environment:

• Circulatory Nurse (Non-Sterile Role) — handles device preparation
• Scrub Nurse (Sterile Role) — assists during procedure
• Surgeon (Sterile Role) — primary device operator

Each user group interacted with the device differently, creating multiple potential points of failure that needed to be analyzed and mitigated.

My Process

I supported a structured task analysis process that moved from high-level task decomposition to specific risk identification:

PCA Analysis: Finding the Root Cause

PCA (Perception, Cognitive, Action) analysis is a method for determining why a use error occurs. I assisted in going through every step in the task workflow to classify potential errors:

• Perception: Did the user fail to notice something? (e.g., didn't see a visual indicator)
• Cognition: Did the user misunderstand? (e.g., didn't recognize the feature's importance)
• Action: Did the user make a physical error? (e.g., incorrect grip or motion)

Finding: Users did not perceive the innovative feature as important—a perception-level issue that informed our mitigation strategy.

FMEA: Quantifying Risk

I contributed to Failure Mode and Effects Analysis (FMEA), which quantifies risk using three factors:

• Severity (S): Impact of the failure if it occurs
• Probability (P): Likelihood of the failure occurring
• Detectability (D): How easily the failure can be detected before harm

I was tasked with identifying failure modes with high severity ratings—the most critical risks that could impact patient safety.

Cross-Functional Collaboration

Risk mitigation at J&J MedTech required input from multiple disciplines. I participated in cross-functional meetings that included:

• Risk Management Specialists
• Surgical Consultants (clinical perspective)
• Human Factors Engineers
• Regulatory Specialists

These sessions focused on prioritizing the most critical risks and developing mitigation strategies that balanced user safety, regulatory requirements, and practical constraints.

Outcome

Additional Contributions

Gap Analysis Work

Beyond task analysis, I collaborated with senior engineers on gap analyses of Usability Engineering Plans across multiple business units:

• Helped evaluate existing UEPs against new FDA guidance and IEC 62366-1
• Assisted in identifying deviations and areas requiring updates
• Contributed to cross-divisional alignment between Cincinnati and New Jersey sites

UEP Map Redesign (Independent Initiative)

I took initiative on redesigning a UEP map in Figma—leveraging my design background to improve how teams navigate human factors documentation. This created visual tools that made regulatory requirements more accessible to cross-functional teams.

What I Learned

This co-op shaped how I approach human factors engineering:

• PCA analysis is critical for identifying root causes of use errors— knowing why an error happens determines how you fix it
• Cross-disciplinary collaboration is essential—regulatory, clinical, and design perspectives all inform risk mitigation strategies
• Balancing constraints matters—solutions must be practical, legally sound, and cost-effective while remaining user-centered
• Documentation rigor at enterprise scale requires systems thinking and attention to detail

Methods & Standards Applied