Human Factors Engineer

Role:
Sr. Human Factors Design Engineer – Medical Device

Location: Minneapolis, MN (Fully Onsite)

Job Type: W2 Contract

Duration: 12+ Months

We are seeking an experienced Sr. Human Factors Design Engineer with 5–20 years of experience in Human Factors Engineering
, Usability Engineering
, and Medical Device Development
. The ideal candidate will have hands-on experience conducting Human Factors Validation Studies
, Use-Related Risk Analysis (URRA), and collaborating with cross-functional engineering teams to improve product safety and usability.

• Usability Engineering & Validation
• Use-Related Risk Analysis (URRA)
• Medical Device Development
• Human Factors Validation Testing
• Study Design & Protocol Development
• Data Analysis & Report Writing
• Cross-Functional Collaboration
• FDA / IEC 62366 Usability Engineering

• 5–20 years of Human Factors or Usability Engineering experience
• Medical Device or Regulated Product Development
• Formative & Usability Testing
• Study Design, Protocol Development & Execution
• Use-Related Risk Analysis (URRA)
• Data Analysis & Technical Report Writing
• User Research & Human-Machine Interaction
• Statistical Analysis
• Cross-Functional Collaboration (R&D, Quality, Regulatory)
• Excellent Communication & Problem-Solving Skills

• Plan, design, and execute Human Factors usability validation studies
  .
• Develop validation protocols, conduct testing, analyze data, and prepare technical reports.
• Create and update Use-Related Risk Analysis (URRA) documentation.
• Identify usability risks and recommend design improvements.
• Collaborate with Engineering, Quality, Regulatory, and Product Development teams.
• Support safe and effective medical device design throughout the product development lifecycle.
• Ensure compliance with medical device usability and quality standards.

• Bachelor's degree in human Factors, Biomedical Engineering, Industrial Engineering, Psychology, Engineering, or a related field.
• 5+ years of Human Factors Engineering experience.
• Strong experience in Usability Validation
  , URRA
  , and Medical Device Development
  .
• Experience working in a regulated industry is highly preferred.
• Excellent analytical, technical writing, and communication skills.