Senior Human Factors Engineer — Medical Devices & FDA

SRG; Pittsburgh (Allegheny County); Hybrid; USD 83,000 - 117,000; Full time

Job summary

SRG is seeking a Senior Human Factors Engineer (Contract) to support medical devices via user-centered design, usability engineering, and regulatory compliance in a hybrid Indianola, PA setting. The assignment is for 1 year+ extensions with a pay rate of $70/hr.

The ideal candidate will independently drive HF activities, lead GUI evaluations, and contribute to FDA submissions such as 510(k) documentation while coordinating with cross-functional teams to ensure risk management and user needs are

Qualifications

• Bachelor's degree in a related field (HF/IE/psychology/biomed).
• 5+ years in Human Factors or Usability within regulated industries.
• Experience supporting medical device development and FDA-regulated products.
• Demonstrated 510(k) submissions experience and HF documentation.
• Strong use-error identification, formative studies, and validation reporting.

Responsibilities

• Lead and execute human factors and usability activities across development lifecycle.
• Support design and evaluation of electromechanical medical devices and GUIs.
• Conduct formative and summative usability studies per FDA standards.
• Identify and mitigate use-related risks with use error analysis and risk management.
• Contribute to regulatory submissions and HF deliverables (510(k)).
• Collaborate with engineering, quality, regulatory, clinical, and product teams.
• Develop study protocols, moderation guides, reports, and documentation.
• Interpret FDA HF guidance and ensure regulatory alignment.
• Present findings and risk assessments to teams and leadership.

Skills

Human Factors

Usability Engineering

Regulated Industry

FDA Submissions

510(k)

Lead Independent

GUI Evaluation

Risk Analysis

Communication

Education

Bachelor's in Human Factors Engineering / related field

Job description

SRG is seeking a Senior Human Factors Engineer (Contract) to support medical devices via user-centered design, usability engineering, and regulatory compliance in a hybrid Indianola, PA setting. The assignment is for 1 year+ extensions with a pay rate of $70/hr.

The ideal candidate will independently drive HF activities, lead GUI evaluations, and contribute to FDA submissions such as 510(k) documentation while coordinating with cross-functional teams to ensure risk management and user needs are