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Job Details

This principal human factors engineer will provide leadership and guidance to ensure the organization develops innovative medical products that focus on the quality, effectiveness and efficiency of the user experience. The candidate shall be responsible for being the subject matter expert for process, procedures and guidelines involving human factors engineering. Lead user and customer usability, formative usability and usability validation studies. Leading product requirement development by applying user centered design and development methods. Assisting in translating outcomes of studies into technical requirements, technical documentation and specifications.

Essential Duties

• Conducting human factors analyses, summative and formative usability studies. Owns protocol design, study execution, data collection, report creation and review/release
• Investigates and defines usability requirements for product requirements that address human factors engineering process and appropriately mitigate use related risks
• Expert in relevant usability standards and risk management such as IEC 62366-1, ANSI HE75, ISO 14971 and FDA guidance
• Contributes to the design development process by participating in design review meetings, reviewing, and contributing to design inputs, risk analysis, and reviewing and testing new product performance.
• Responsible for HF assessments included in regulatory documents
• Develop and Maintain SOP’s that are compliant to applicable standards and guidances

Supervisory Responsibilities: Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training employees; planning, assigning and directing work; addressing complaints and resolving problems.

Qualifications

Education

Bachelor's Degree: Human Factors Engineering / Systems Engineering - Required

Experience

BS Minimum of 8-10 years, MS 6+years, PhD 4+years

In human factors engineering for a medical device or a highly regulated industry - Required

Experience developing usability requirement and helping translate those into product requirements

Experience developing and leading Formative and Summative usability studies

Experience developing Standard Operating Procedures, Guidelines and Templates for the evaluation of Human Factors and Usability

Skills

• Experience with document development in MS Word or other text editors.
• Strong verbal communication and listening skills
• Experience of using requirement management tools (DOORs, Polarion or cognition cockpit, etc)

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