Senior Human Factors Engineer

Advantage Technical; Santa Clarita (CA); On-site; USD 120,000 - 156,000; Full time

Job summary

Advantage Technical is seeking a Senior Human Factors Engineer to support the development of complex medical devices in Santa Clarita, CA. This contract role offers up to $75/hour with potential conversion to direct hire, reflecting a commitment to long-term collaboration with cross-functional teams.

The role emphasizes planning and executing human factors activities across the lifecycle, with emphasis on formative and summative usability testing, user needs, use-related risk analyses, and

Qualifications

• 4+ years of human factors or usability engineering experience in medical-device development.
• Experience with medical-device hardware, preferably Class III or implantables.
• Hands-on experience moderating usability studies and documenting findings.
• Strong knowledge of IEC 62366.
• Strong knowledge of IEC 60601-1-6.
• Familiarity with FDA Human Factors guidance.
• Excellent written and verbal communication; cross-functional collaboration.

Responsibilities

• Lead human factors and usability engineering activities across medical-device product development.
• Partner with engineering, clinical, regulatory, quality, and marketing teams to incorporate user needs into design.
• Develop study plans and methodologies for qualitative and quantitative usability data.
• Design, moderate, and execute formative and summative usability studies.
• Develop and maintain human factors documentation including user needs, user profiles, task analyses, use-related risk analyses, and test protocols.
• Prepare usability test reports and post-market usability assessments.
• Analyze usability findings and translate results into actionable design improvements.
• Support continuous improvement using post-market and usability data.
• Collaborate with internal teams, customers, contractors, and external partners; ensure compliance with quality systems.

Skills

Human factors

Usability engineering

Regulatory knowledge

Cross-functional collaboration

Communication skills

Problem solving

Education

Bachelor's or higher in Human Factors or related field

Job description

Employment Type: Contract with potential conversion to direct hire

Pay Rate: Up to $75/hour

Position Overview

A leading medical technology organization is seeking a Senior Human Factors Engineer to support the development of complex medical devices.

This individual will partner closely with cross-functional teams including Software, Firmware, Electrical, Mechanical, Systems Engineering, Clinical, Regulatory, Design Assurance, Marketing, and New Product Development.

The role will focus on planning and executing human factors and usability engineering activities throughout the product-development lifecycle, with particular emphasis on formative and summative usability testing, user needs, use-related risk analysis, and regulatory compliance.

Key Responsibilities

• Lead human factors and usability engineering activities supporting medical-device product development.
• Partner with engineering, clinical, regulatory, quality, and marketing teams to incorporate user needs into product design.
• Develop research methodologies and study plans to collect both qualitative and quantitative usability data.
• Design, moderate, and execute formative and summative usability studies that simulate real-world product use.
• Develop and maintain human factors documentation, including:
• User needs
• User profiles
• Task analyses
• Use-related risk and use-error analyses
• Usability test protocols and reports
• Post-market usability assessments
• Analyze usability findings and translate results into actionable design recommendations.
• Support continuous improvement activities using post-market and usability data.
• Collaborate effectively with internal teams, customers, contractors, and external partners.
• Ensure all human factors activities comply with applicable quality-system and regulatory requirements.

Required Qualifications

• 4+ years of relevant human factors or usability engineering experience within medical-device product development, OR a relevant graduate degree with substantial project experience.
• Experience working with medical-device hardware, preferably Class III or implantable products.
• Bachelor's or graduate degree in a relevant field such as:
• Human Factors
• Biomedical Engineering
• Pre-Medical Studies
• Related scientific or engineering discipline
• Hands-on experience moderating usability studies and documenting findings.
• Strong knowledge of:
• IEC 62366
• IEC 60601-1-6
• FDA Human Factors / Usability Engineering guidance
• Strong analytical and problem-solving abilities.
• Excellent written and verbal communication skills.
• Ability to influence cross-functional teams and work effectively with multiple stakeholders.
• Strong organizational skills and attention to detail.
• Ability to work independently as well as within a fast-paced, cross-functional team environment.

Preferred Background

• Experience with Class III medical devices, implantables, or other complex medical-device hardware.
• Experience supporting products through formal design controls and regulatory submissions.
• Familiarity with post-market usability analysis and risk-management activities.

Quality Responsibilities

Build quality into all aspects of work by maintaining compliance with applicable quality-system requirements, internal procedures, and regulatory standards.