Human Factors Engineer / Quality Engineer / Risk Management Engineer / Usability Engineer

Our Client, a American Biotechnology company, is looking for a Human Factors Engineer / Quality Engineer / Risk Management Engineer / Usability Engineer for their Remote location.

Responsibilities:

• 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 client 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).
• Medical device experience mandatory, no exceptions.
• Hands-on experience with remediation of risk assessment documents.
• Design controls and risk analysis background.
• Human factors methodologies.
• Regulatory knowledge (IEC 62366, AAMI HE75, FDA human factor).
• Traceability/PLM tools (Polarion, Windchill, Agile PDM, or equivalent).
• Preferred: 5-8 years
• Flexible up to 15-20 years - as long as the candidate can keep pace with the work.

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities