Manager, Human Factors Validation
Irvine, CA Irvine, CA Full-time Full-time $130,000 - $194,000 a year $130,000 - $194,000 a year Job
Summary:
Responsible for leading and managing human factors validation activities within the company.
Works closely with cross-functional teams, including design, engineering, marketing, and regulatory affairs, to ensure that medical devices, products, or systems are designed and validated to be safe, effective, and user-friendly for their intended users.
Responsible for planning, coordinating, and executing human factors validation studies, analyzing results, and providing recommendations for design improvements to enhance usability and safety.
Utilizes strong project management skills, a deep understanding of human factors engineering principles, and the ability to effectively communicate and collaborate with stakeholders at all levels of the organization.
Duties &
Responsibilities:
Develop and implement human factors validation plans, protocols, and reports in accordance with relevant regulations, standards, and guidelines (e.
g.
, FDA Human Factors Guidance, IEC 62366-1, IEC 60601-1-6).
Collaborate with cross-functional teams to integrate human factors validation activities into the product development process, from concept development to post-market surveillance.
Lead and manage human factors validation studies, including participant recruitment, data collection, and analysis.
Conduct task analysis, use-related risk assessments, and other human factors engineering activities to identify potential use errors and hazards.
Interpret and analyze human factors validation data to identify usability issues, develop recommendations for design improvements, and ensure that products meet usability requirements.
Collaborate with design, engineering, and regulatory affairs teams to implement design changes based on human factors validation findings and to develop strategies for mitigating use-related risks.
Stay up to date with the latest human factors engineering regulations, standards, and industry best practices, and provide guidance to cross-functional teams to ensure compliance.
Collaborate with external vendors or consultants, as needed, for conducting human factors validation studies or other related activities.
Participate in audits and inspections related to human factors engineering and usability and assist with resolving any findings or issues identified.
Support regulatory submissions by providing human factors validation documentation.
Perform other duties and projects as assigned.
Minimum & Preferred Qualifications and
Experience:
Minimum
Qualifications:
Minimum 5 years of experience in human factors engineering or usability validation in the medical device or pharmaceutical industry.
Experience in planning, conducting, and analyzing human factors validation studies.
Experience in writing human factors summative reports for FDA submissions.
Knowledge of FDA regulations and standards related to human factors engineering and usability in the medical device industry.
Strong understanding of human factors engineering principles.
Strong project management skills.
Excellent analytical skills, with the ability to interpret and analyze data related to human factors validation.
Excellent writing and communication skills.
Preferred
Qualifications:
N/A Education:
Bachelor's or Master's degree in Human Factors Engineering, Industrial Design, Biomedical Engineering, or a related field.
Job Type:
Full-time Pay:
$130,000.
00 - $194,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Employee discount Health insurance Life insurance Paid time off Vision insurance Schedule:
Day shift Monday to Friday Supplemental pay types:
Bonus pay Ability to commute/relocate:
Irvine, CA 92618:
Reliably commute or planning to relocate before starting work (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
Summary:
Responsible for leading and managing human factors validation activities within the company.
Works closely with cross-functional teams, including design, engineering, marketing, and regulatory affairs, to ensure that medical devices, products, or systems are designed and validated to be safe, effective, and user-friendly for their intended users.
Responsible for planning, coordinating, and executing human factors validation studies, analyzing results, and providing recommendations for design improvements to enhance usability and safety.
Utilizes strong project management skills, a deep understanding of human factors engineering principles, and the ability to effectively communicate and collaborate with stakeholders at all levels of the organization.
Duties &
Responsibilities:
Develop and implement human factors validation plans, protocols, and reports in accordance with relevant regulations, standards, and guidelines (e.
g.
, FDA Human Factors Guidance, IEC 62366-1, IEC 60601-1-6).
Collaborate with cross-functional teams to integrate human factors validation activities into the product development process, from concept development to post-market surveillance.
Lead and manage human factors validation studies, including participant recruitment, data collection, and analysis.
Conduct task analysis, use-related risk assessments, and other human factors engineering activities to identify potential use errors and hazards.
Interpret and analyze human factors validation data to identify usability issues, develop recommendations for design improvements, and ensure that products meet usability requirements.
Collaborate with design, engineering, and regulatory affairs teams to implement design changes based on human factors validation findings and to develop strategies for mitigating use-related risks.
Stay up to date with the latest human factors engineering regulations, standards, and industry best practices, and provide guidance to cross-functional teams to ensure compliance.
Collaborate with external vendors or consultants, as needed, for conducting human factors validation studies or other related activities.
Participate in audits and inspections related to human factors engineering and usability and assist with resolving any findings or issues identified.
Support regulatory submissions by providing human factors validation documentation.
Perform other duties and projects as assigned.
Minimum & Preferred Qualifications and
Experience:
Minimum
Qualifications:
Minimum 5 years of experience in human factors engineering or usability validation in the medical device or pharmaceutical industry.
Experience in planning, conducting, and analyzing human factors validation studies.
Experience in writing human factors summative reports for FDA submissions.
Knowledge of FDA regulations and standards related to human factors engineering and usability in the medical device industry.
Strong understanding of human factors engineering principles.
Strong project management skills.
Excellent analytical skills, with the ability to interpret and analyze data related to human factors validation.
Excellent writing and communication skills.
Preferred
Qualifications:
N/A Education:
Bachelor's or Master's degree in Human Factors Engineering, Industrial Design, Biomedical Engineering, or a related field.
Job Type:
Full-time Pay:
$130,000.
00 - $194,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Employee discount Health insurance Life insurance Paid time off Vision insurance Schedule:
Day shift Monday to Friday Supplemental pay types:
Bonus pay Ability to commute/relocate:
Irvine, CA 92618:
Reliably commute or planning to relocate before starting work (Required) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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