IL
Human Factors Engineer / Quality Engineer / Risk Management Engineer / Usability Engineer
ICONMA, LLC
🇺🇸 United States
Remote
2 months ago
$67.41 – $72.41 / hour
- Risk Management
- Agile
- IEC
- Windchill
2 months ago
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
Human Factors Engineer / Quality Engineer / Risk Management Engineer / Usability Engineer · ICONMA, LLC