Human Factors Engineer

REQ Solutions; Santa Clarita (CA); Hybrid; USD 90,000 - 140,000; Full time

Job summary

REQ Solutions in California seeks a Human Factors Engineer to lead usability engineering for medical device development. You will partner with software, firmware, electrical, mechanical, and systems teams to shape user-centered design and risk mitigation.

You will design studies, develop methodologies for qualitative and quantitative data, and conduct formative and summative usability testing in a hybrid environment. IEC 62366 and FDA Human Factors knowledge is essential.

Qualifications

• 4+ years of relevant work experience in medical device product development.
• Degree types include Pre-med, Human Factors, Psychology, Bio-med, or related.
• Experience with IEC 62366, 60601-1-6 and FDA Human Factors guidelines.
• Experience moderating usability sessions and documenting findings.

Responsibilities

• Perform human usability engineering activities in partnership with engineering groups.
• Develop research methodologies to collect qualitative and quantitative data.
• Design and execute formative and summative usability tests to simulate product use.
• Support and author deliverables related to user needs, user profiles, use scenarios, task and use error analysis, usability testing, and post-market usability analysis for continuous improvement.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors, and across multiple disciplines.

Skills

Analytical thinking

Team collaboration

Usability testing moderation

Communication skills

Education

Pre-med, Human Factors, Psychology, Bio-med or related

Job description

Duration: 12+ Months (Possible temp to hire)

Hybrid Role

Responsibilities:

• Perform human usability engineering activities in partnership with functional engineering groups (Software, Firmware, Electrical, Mechanical and Systems), new product planning, clinical, design assurance, regulatory, and marketing.
• Develop research methodologies to collect both qualitative and quantitative data, as needed.
• Design and execute both formative and summative usability tests to simulate product use.
• Support and author deliverables related to user needs, development of user profiles, use scenarios, task and use error analysis, usability testing, and post-market usability analysis for continuous improvement.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors, and across multiple disciplines

Education/Experience:

• 4+ Years of relevant work experience in medical device product development and/or a graduate degree with a relevant project experience.
• Degree types: Pre-med, Human Factors, Psychology, Bio-med, related.
• Prior experience working with medical device hardware (ideally class III, implantable)
• Strong analytical and problem-solving skills in a team environment
• Experience moderating usability sessions and documenting findings
• Ability to work within a team and as an individual contributor in a fast-paced, dynamic environment
• Knowledge of IEC 62366, 60601-1-6 and FDA guidelines for Human Factors.