Human Factors Engineer Jobs

About The Position

Requirements

• Doctorate degree; or a master’s degree and 2 years of human factors engineering/usability engineering experience in the biomedical, pharmaceutical, or medical device field; or a bachelor’s degree and 4 years of such experience; or an associate’s degree and 8 years of such experience; or a high school diploma/GED and 10 years of such experience.
• Experience in human factors engineering or usability engineering in the biomedical, pharmaceutical, or medical device field, as applicable to the stated education pathway.

Nice To Haves

• Bachelor’s or master’s degree in human factors, usability engineering, psychology, industrial design, engineering, or a relevant discipline, and 5–7 years of industry experience in multifunctional, fast-paced corporate environments.
• Experience with design and manufacturing of injectable devices, such as autoinjectors, pens, needle-free injectors, and syringes, or non-invasive/minimally invasive drug-delivery devices, such as pulmonary or transdermal systems.
• Experience planning, coordinating, conducting, analyzing, and reporting human factors studies without vendor support.
• Experience with ethnographic research, interviews, contextual inquiries, focus groups, technical assessments, device user-interface evaluation, knowledge and comprehension studies, professional analysis, task analysis, hazard analysis, risk assessment, and formative and summative studies.
• Experience working directly with users to gather and synthesize research, develop product concepts and features, and evaluate user interfaces and ergonomic designs.
• Experience using low- and high-fidelity prototypes to identify and eliminate potential use errors early in development.
• Experience in development organizations, particularly virtual development environments.
• Experience with systems design, verification, and validation in development organizations.
• Practical knowledge of applicable FDA human factors guidance, regulations, and standards, including IEC 62366, AAMI HE75, EN 60601 1-6, ISO 14971, MDR, and design controls.

Responsibilities

• Partner with engineering, operations, regulatory, risk, quality, clinical, drug product, digital health, and commercial teams to help ensure products are safe and effective for end users.
• Lead and support human factors and usability engineering activities to improve device-user interface design, including devices, packaging, labeling, and instructions for use.
• Develop and implement a risk-prioritized, fit-for-purpose approach to human factors activities.
• Ensure human-system capabilities and limitations are reflected in system requirements and provide human factors input across functions for device design, packaging, labeling, and training requirements.
• Identify and conduct appropriate activities to improve device-user interfaces and minimize potential use errors.
• Analyze objective and subjective usability-study data to inform product design, identify and mitigate use risk, and develop solutions.
• Lead the design and execution of formative and summative human factors activities, including moderation, note taking, vendor engagement, and data analysis.
• Provide human factors expertise for clinical study preparation and regulatory submissions in accordance with applicable best practices, guidance, and standards.
• Create development and design-control documentation, including protocols, task analyses, use-related risk analyses, usability technical assessments, human factors validation reports, and regulatory submission materials.
• Communicate regularly with internal and external partners.

Benefits

• Comprehensive employee benefits package, including a retirement and savings plan with company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.
• Work/life balance and career development opportunities.