Human Factors Specialist(Medical device)
2 weeks ago
Key Responsibilities
- Human Factors Integration: Apply principles of human factors, including cognitive, perceptual, and motor skills, to design and evaluate cardiac electrophysiology systems.
- Collaboration & Leadership: Oversee staff and consultants on human factors tasks, fostering effective cross-functional collaboration.
- Regulatory Compliance:
- Work with regulatory teams on new product submissions, develop submission packages, and respond to regulatory inquiries.
- Ensure that usability engineering methodologies meet regulatory standards and enhance value for customers.
- Stay current on human factors regulations and best practices, advising management on process improvements and compliance.
- Deliverables:
- Develop usability engineering files, task analyses, and usability risk assessments.
- Conduct usability testing at all stages of product development, from formative testing of prototypes to usability validation of final designs.
- Strong knowledge of human factors and usability engineering principles.
- Proven ability to work collaboratively with multidisciplinary teams.
- Professional experience interfacing directly with clients.
- Familiarity with medical device standards (e.g., IEC 62366, AAMI HE75, ISO 14971) and regulatory requirements for human factors engineering.
- Excellent communication and presentation skills.
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Human Factors Specialist(Medical device)
2 weeks ago
saint paul, United States Intellectt Inc Full timeKey ResponsibilitiesHuman Factors Integration: Apply principles of human factors, including cognitive, perceptual, and motor skills, to design and evaluate cardiac electrophysiology systems.Collaboration & Leadership: Oversee staff and consultants on human factors tasks, fostering effective cross-functional collaboration.Regulatory Compliance:Work with...
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Human Factors Specialist(Medical device)
2 weeks ago
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