Senior Human Factors Engineer (Medical Devices)

Location: Thousand Oaks, California, United States. The role may require up to 20% yearly travel, mostly local and domestic.

Company

hirify.global is a biotechnology company that researches, manufactures, and delivers medicines across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead human factors and usability engineering planning, research, development, and continuous improvement for drug delivery devices.
• Improve device-user interfaces, packaging, labeling, instructions for use, and training requirements to support safe and effective product use.
• Design and execute formative and summative usability studies, including methodology, moderation, data collection, analysis, and reporting.
• Analyze usability data, conduct root cause and use-risk analysis, and translate findings into product design improvements.
• Provide human factors expertise for clinical studies, design controls, development files, and regulatory submissions.
• Collaborate with engineering, operations, regulatory, risk, quality, clinical, manufacturing, commercial, and external partners.

Requirements

• Doctorate degree, or a master's degree with 2 years, bachelor's degree with 4 years, associate's degree with 8 years, or high school diploma/GED with 10 years of Human Factors Engineering or Usability Engineering experience in the biomedical, pharmaceutical, or medical device field.
• Experience applying human factors and usability engineering methods to medical devices or combination products.
• Experience with usability studies, user research, task analysis, hazard analysis, risk assessment, and formative and summative evaluations.
• Ability to analyze objective and subjective usability data and develop solutions that reduce use errors.
• Experience preparing protocols, task analyses, use-related risk analyses, usability assessments, validation reports, and regulatory submissions.
• Knowledge of FDA human factors guidance and relevant standards, including IEC 62366, AAMI HE75, EN 60601-1-6, ISO 14971, MDR, and design controls.

Nice to have

• Bachelor's or master's degree in Human Factors, Usability Engineering, Psychology, Industrial Design, or Engineering, with 5–7 years of industry experience.
• Experience designing and manufacturing injectable or non-invasive/minimally invasive drug delivery devices.
• Experience conducting human factors studies without vendor support and working with low- and high-fidelity prototypes.
• Experience in systems design, verification, validation, and virtual development environments.

Culture & Benefits

• Collaborative, innovative, science-based work environment focused on serving patients.
• Comprehensive health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions, stock-based long-term incentives, and an annual bonus program.
• Paid time-off plans and career development opportunities.
• Flexible work models where applicable to the assigned work location type.

Hiring process

• Applications are accepted until a sufficient number of candidates apply or a candidate is selected; there is no fixed application deadline.
• Sponsorship for the role is not guaranteed.