Job Description
Senior Human Factors Design Engineer
Minneapolis, MN
Job Description:
We are seeking a Senior Human Factors Design Engineer with experience in human factors engineering, usability testing, and risk analysis for Class III medical devices.
Key Skills & Responsibilities:
Human Factors Engineering (HFE) and usability engineering for medical devices.
Human Factors validation study design and execution.
Moderating formative, presummative, and summative usability studies.
Developing and executing usability testing protocols.
Authoring Use-Related Risk Analyses (URRA).
Identifying and analyzing use-related risks and maintaining accurate risk traceability.
Developing research methodologies and statistical analysis plans.
Conducting usability data analysis and interpreting study results.
Preparing detailed usability study reports and validation documentation.
Identifying design improvements based on usability data.
Collaborating with HFE, systems engineering, and design engineering teams.
Supporting participant recruitment and usability study logistics.
Developing human–machine interface requirements and design recommendations.
Conducting human factors investigations and risk assessments.
Experience with Class III medical devices and clinician-facing medical device systems.
Experience with Figma is a plus.
Required Experience:
5–10 years of experience in Human Factors Engineering, Usability Engineering, or a related field.
Experience with medical device usability validation and regulatory documentation.
Strong technical writing, data analysis, and cross-functional collaboration skills.
Product Focus:
Sacral Neuromodulation Systems
Clinician-facing medical device components
Work Arrangement:
Onsite: 4 days per week.
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