Human Factors Design Controls Engineer (level 3 or higher)

ICONMA is a Medical Technology company seeking a Human Factors Design Controls Engineer (level 3 or higher) for their remote location. The role involves working closely with the Human Factors team to develop and maintain usability engineering documentation and support regulatory submissions for medical devices.

Responsibilities:

• As part of the Intuitive Human Factors team, the Human Factors Design Controls Engineer works closely with fellow HF team members and department leadership and other cross functional partners. The Human Factors Design Controls Engineer is a key contributor to inform, guide development of, and maintain usability engineering documentation produced during product development projects. Responsibilities are focused on comprehensive and timely implementation of task analysis and related risk analysis documents
• This role supports the Human Factors Engineering team with expertise in design controls and helps create usability engineering documentation required for submission to global medical device regulatory agencies
• This role provides dedicated support and subject matter expertise guidance to the broader human factors engineering team serving all business units and reports to a human Factors team lead. For reference, a brief description of each of the business units is as follows
• Support remediation of usability related risk analysis documentation, including revising, editing and reformatting, collating and tracing of task analysis and usability risk analysis document content
• Support definition, release and maintenance of usability related design inputs documentation
• Create and maintain tracing documentation with the Polarion tracing environment to Identify and resolve tracing conflicts and design input orphans in tracing between risks and design inputs/risk controls
• Using Intuitive laptop, software and administrative systems

Requirements:

• Minimum Education: BS in Human Factors Engineering, Biomedical Science or Engineering, Systems Engineering, Quality Engineering, Information and Data Science, Cognitive Psychology, Computer Science with human-computer interface (HCI) emphasis, Human Centered Design, or related field
• Minimum of 5 years of related experience with a bachelor's degree in engineering, and have experience design controls, risk remediation, and risk analysis related medical device product development (or related field)
• Experience working with Digital project collaboration tools is required. (e.g. Polarion, Agile PDM, Smartsheets etc.)
• Background and understanding of MDR regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices)
• Excellent verbal communication and presentation skills working within a highly statured communication environment using multiple communication channels (email, text, video conference, instant messaging platforms)