Cynet systems Inc
Job Description
Pay Range: $50hr - $58hr
Roles and Responsibilities
The Senior Human Factors Engineer will play a key role in driving usability engineering activities across product development, sustaining engineering, and regulatory compliance.
This role will focus on ensuring best practices for task analysis, usability risk management, design controls, and human factors validation, with an emphasis on medical device development and global regulatory requirements.
The engineer will collaborate across teams, mentor colleagues, and contribute to continuous improvement of usability engineering processes.
Research
Support the definition, release, and maintenance of task analyses and comparative task analyses documentation to ensure consistency across multi-level documents.
Generate and maintain known use problem documentation (quality data review equivalent).
Support definition and release of Usability Engineering Plan documents.
Design
Support the creation, release, and maintenance of usability-related risk documentation.
Define, release, and maintain usability-related design input documentation.
Create and maintain usability tracing documentation.
Test
Guide the Human Factors team in best practices for defining validation test cases.
Support proper tracing between task analysis, risks, design inputs, and test cases.
Analyze
Identify and resolve tracing conflicts, design input gaps, or orphans in documentation.
Ensure alignment between risks, design inputs, and risk controls.
Sustain and Improve
Analyze complaints from on-market products, update usability risk assessments, and escalate usability-related issues as needed.
Stay current with MDR regulations and best practices (IEC 62366, AAMI HE75, FDA guidelines) and advise management on process improvements and compliance issues.
Contribute to continuous improvement of usability engineering processes through subject matter expertise in design controls.
Collaborate
Lead usability risk analyses for company products.
Represent Human Factors Design Controls on cross-functional core teams for major projects.
Coordinate human factors efforts across multiple projects and subsystems.
Mentor junior human factors engineers, interns, and colleagues in design control methods, best practices, and product development processes.
Qualifications
Bachelor’s degree in Human Factors Engineering, Biomedical Science/Engineering, Systems Engineering, Quality Engineering, Cognitive Psychology, Human-Centered Design, Computer Science (with HCI focus), or related field.
Minimum of 8 years of relevant experience in engineering, design controls, or medical device product development.
Excellent verbal communication and presentation skills across diverse communication channels (email, video conference, instant messaging).
Experience with digital project collaboration tools (e.g., Polarion, Agile, Python, Smartsheets).
Strong ability to collaborate with engineering, clinical, marketing, and regulatory teams to solve complex usability issues involving detailed risk analysis.
Ability to travel up to 15% domestically and internationally.
Preferred Attributes
Advanced experience with human factors and usability engineering in regulated industries, particularly medical devices.
Demonstrated ability to lead cross-functional usability risk analysis efforts.
Proven mentoring and leadership capabilities in design controls and usability practices.
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Roles and Responsibilities
The Senior Human Factors Engineer will play a key role in driving usability engineering activities across product development, sustaining engineering, and regulatory compliance.
This role will focus on ensuring best practices for task analysis, usability risk management, design controls, and human factors validation, with an emphasis on medical device development and global regulatory requirements.
The engineer will collaborate across teams, mentor colleagues, and contribute to continuous improvement of usability engineering processes.
Research
Support the definition, release, and maintenance of task analyses and comparative task analyses documentation to ensure consistency across multi-level documents.
Generate and maintain known use problem documentation (quality data review equivalent).
Support definition and release of Usability Engineering Plan documents.
Design
Support the creation, release, and maintenance of usability-related risk documentation.
Define, release, and maintain usability-related design input documentation.
Create and maintain usability tracing documentation.
Test
Guide the Human Factors team in best practices for defining validation test cases.
Support proper tracing between task analysis, risks, design inputs, and test cases.
Analyze
Identify and resolve tracing conflicts, design input gaps, or orphans in documentation.
Ensure alignment between risks, design inputs, and risk controls.
Sustain and Improve
Analyze complaints from on-market products, update usability risk assessments, and escalate usability-related issues as needed.
Stay current with MDR regulations and best practices (IEC 62366, AAMI HE75, FDA guidelines) and advise management on process improvements and compliance issues.
Contribute to continuous improvement of usability engineering processes through subject matter expertise in design controls.
Collaborate
Lead usability risk analyses for company products.
Represent Human Factors Design Controls on cross-functional core teams for major projects.
Coordinate human factors efforts across multiple projects and subsystems.
Mentor junior human factors engineers, interns, and colleagues in design control methods, best practices, and product development processes.
Qualifications
Bachelor’s degree in Human Factors Engineering, Biomedical Science/Engineering, Systems Engineering, Quality Engineering, Cognitive Psychology, Human-Centered Design, Computer Science (with HCI focus), or related field.
Minimum of 8 years of relevant experience in engineering, design controls, or medical device product development.
Excellent verbal communication and presentation skills across diverse communication channels (email, video conference, instant messaging).
Experience with digital project collaboration tools (e.g., Polarion, Agile, Python, Smartsheets).
Strong ability to collaborate with engineering, clinical, marketing, and regulatory teams to solve complex usability issues involving detailed risk analysis.
Ability to travel up to 15% domestically and internationally.
Preferred Attributes
Advanced experience with human factors and usability engineering in regulated industries, particularly medical devices.
Demonstrated ability to lead cross-functional usability risk analysis efforts.
Proven mentoring and leadership capabilities in design controls and usability practices.
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