ECI
Human Factors and Usability Engineer #8897
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Human Factors and Usability Engineer #8897
role at
ECI
About ECI ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
Brief Description We are seeking a Human Factors & Usability Engineer to support a remediation program addressing usability-related gaps within our client medical device portfolio. The engineer will ensure product risk controls, and user interface design fully meet FDA, EU MDR, and IEC 62366-1 expectations. This role involves conducting gap assessments, updating usability engineering files (UEF), planning and executing human factors activities, and partnering with cross-functional teams to close regulatory findings.
Key Responsibilities
Remediation & Compliance
Perform detailed gap analyses of existing Human Factors Engineering (HFE) documentation against FDA Guidance (2016), IEC 62366-1, ISO 14971, and Notified Body requirements.
Develop and update usability engineering files, including user profiles, use specifications, task analyses, use‑related risk analyses (URRA), and usability validation plans/reports.
Remediate usability deficiencies identified by EU MDR regulatory submissions.
Risk Management
Conduct use‑related risk analyses and link user interface hazards to design mitigations and risk controls.
Collaborate with risk management teams to ensure alignment between HF documentation and ISO 14971‑compliant risk files.
Human Factors Studies
Support planning, execution, and reporting of formative evaluations, summative usability validation, heuristic evaluations, cognitive walkthroughs, and simulated‑use studies.
Work with external HF vendors and in‑house labs to run usability testing, when needed.
Cross‑Functional Collaboration
Work closely with engineering, quality, regulatory affairs, clinical, and program management teams.
Required Qualifications
Bachelor’s or Master’s degree in Human Factors Engineering, Usability Engineering, Cognitive Psychology, Biomedical Engineering, or related field.
2–5+ years of industry experience in medical device HFE, usability engineering, or user‑centered design.
Working knowledge of:
FDA HFE Guidance (2016)
IEC 62366-1
ISO 14971
ISO 13485 and design control processes
EU MDR Requirements
Experience participating in or leading formative/usability studies.
Strong technical writing, documentation, and root‑cause analysis skills.
Experience supporting remediation, CAPA, audits, or regulatory response activities.
Preferred Qualifications
Experience with EU MDR technical documentation updates.
Prior involvement in risk‑based remediation or large‑scale regulatory compliance projects.
Understanding of Class II/III surgical medical devices.
Core Competencies
Detail‑oriented and comfortable working with structured documentation.
Strong communication skills and the ability to explain HF principles to non‑HF stakeholders.
Ability to prioritize and manage multiple remediation tasks in a fast‑paced environment.
Collaborative mindset with a proactive, problem‑solving approach.
ECI is an equal opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.
At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment‑based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.
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Human Factors and Usability Engineer #8897
role at
ECI
About ECI ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
Brief Description We are seeking a Human Factors & Usability Engineer to support a remediation program addressing usability-related gaps within our client medical device portfolio. The engineer will ensure product risk controls, and user interface design fully meet FDA, EU MDR, and IEC 62366-1 expectations. This role involves conducting gap assessments, updating usability engineering files (UEF), planning and executing human factors activities, and partnering with cross-functional teams to close regulatory findings.
Key Responsibilities
Remediation & Compliance
Perform detailed gap analyses of existing Human Factors Engineering (HFE) documentation against FDA Guidance (2016), IEC 62366-1, ISO 14971, and Notified Body requirements.
Develop and update usability engineering files, including user profiles, use specifications, task analyses, use‑related risk analyses (URRA), and usability validation plans/reports.
Remediate usability deficiencies identified by EU MDR regulatory submissions.
Risk Management
Conduct use‑related risk analyses and link user interface hazards to design mitigations and risk controls.
Collaborate with risk management teams to ensure alignment between HF documentation and ISO 14971‑compliant risk files.
Human Factors Studies
Support planning, execution, and reporting of formative evaluations, summative usability validation, heuristic evaluations, cognitive walkthroughs, and simulated‑use studies.
Work with external HF vendors and in‑house labs to run usability testing, when needed.
Cross‑Functional Collaboration
Work closely with engineering, quality, regulatory affairs, clinical, and program management teams.
Required Qualifications
Bachelor’s or Master’s degree in Human Factors Engineering, Usability Engineering, Cognitive Psychology, Biomedical Engineering, or related field.
2–5+ years of industry experience in medical device HFE, usability engineering, or user‑centered design.
Working knowledge of:
FDA HFE Guidance (2016)
IEC 62366-1
ISO 14971
ISO 13485 and design control processes
EU MDR Requirements
Experience participating in or leading formative/usability studies.
Strong technical writing, documentation, and root‑cause analysis skills.
Experience supporting remediation, CAPA, audits, or regulatory response activities.
Preferred Qualifications
Experience with EU MDR technical documentation updates.
Prior involvement in risk‑based remediation or large‑scale regulatory compliance projects.
Understanding of Class II/III surgical medical devices.
Core Competencies
Detail‑oriented and comfortable working with structured documentation.
Strong communication skills and the ability to explain HF principles to non‑HF stakeholders.
Ability to prioritize and manage multiple remediation tasks in a fast‑paced environment.
Collaborative mindset with a proactive, problem‑solving approach.
ECI is an equal opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.
At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment‑based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.
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