Senior Human / Usability Engineer

Location: Indianola, PA (Hybrid, 3 days, but can be flexible)
Duration: 1 year+ extensions
Pay Rate: $70/hr
INTERVIEW BLOCK: 09/24-09/25

Ideal Candidate Profile
The ideal candidate is a seasoned Human Factors Engineer who can quickly integrate into an existing team, independently drive usability engineering activities, and provide expert guidance on FDA-compliant human factors practices. They bring strong experience supporting medical device programs, demonstrate deep knowledge of use-related risk analysis, and have successfully contributed to 510(k) submissions and usability validation efforts.

Senior Human / Usability Engineer (Contract)
Position Overview
We are seeking a Senior Human Factors Engineer to support the development and validation of medical devices through user-centered design, usability engineering, and regulatory compliance activities. This individual will serve as an experienced contributor capable of working independently with minimal supervision and partnering with cross-functional teams to ensure products meet user needs, regulatory requirements, and risk management standards.
Key Responsibilities

• Lead and execute human factors and usability engineering activities throughout the product development lifecycle.
• Support the design and evaluation of electromechanical medical devices and associated Graphical User Interfaces (GUIs).
• Conduct and document formative and summative usability studies in accordance with FDA and industry standards.
• Identify, analyze, and mitigate use-related risks through comprehensive use error analysis and risk management processes.
• Contribute to regulatory submissions, including 510(k) documentation and human factors engineering deliverables.
• Collaborate with engineering, quality, regulatory, clinical, and product development teams to ensure usability requirements are incorporated into product design.
• Develop study protocols, moderation guides, reports, and supporting documentation for regulatory and internal stakeholders.
• Interpret FDA human factors guidance and ensure compliance with current regulatory expectations.
• Present findings, recommendations, and risk assessments to project teams and leadership.

Required Qualifications

• Bachelor's degree in Human Factors Engineering, Industrial Engineering, Cognitive Psychology, Biomedical Engineering, or a related field.
• 5+ years of Human Factors Engineering, Usability Engineering, or related experience within a regulated industry.
• Experience supporting medical device development and FDA-regulated products.
• Demonstrated experience with 510(k) submissions and human factors documentation.
• Strong background in:
• Use error identification and analysis
• Risk management
• Formative usability studies
• Summative validation studies
• Human factors validation reporting
• Experience with electromechanical devices and user interface evaluation.
• Ability to work independently and lead human factors activities with limited oversight.
• Strong written and verbal communication skills.

Preferred Qualifications

• Experience moderating usability studies.
• Knowledge of FDA Human Factors Guidance and relevant international standards.
• Experience supporting multiple product development programs simultaneously.
• Familiarity with healthcare, pharmaceutical, or combination product environments.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.