Human Factors Design Controls Engineer : 26-02171

Usability Engineering Documentation Specialist

This role is crucial for ensuring the quality and compliance of medical device development by focusing on human factors and usability engineering. You will be responsible for creating and maintaining essential documentation that supports regulatory submissions and guides the design process. Your work will directly impact the safety and effectiveness of innovative medical technologies.

Key Responsibilities:

• Revise and refine risk analysis documentation.
• Assist in defining and maintaining design input requirements.
• Manage traceability between risks and design inputs using specific tools.
• Ensure compliance with relevant regulatory standards.
• Collaborate with cross-functional teams on usability aspects.

Must-Have

Skills:

• Experience with design controls in medical device development.
• Proficiency in risk analysis and remediation.
• Understanding of medical device regulations.

Experience with the medical device industry is required, with a strong emphasis on product development and regulatory compliance.