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

Remote Benefits: 401K, Employee Referral Program, Life Insurance Skills: Agile PDM, Association for the Advancement of Medical Instrumentation (AAMI), Best Practices, Biomedical Engineering, Biotech and Pharmaceutical, Cognitive Psychology, Communication Skills, Computer Science, Data Science, Documentation, FDA (Food and Drug Administration), Health Plan, Human Factors, Human-Computer Interaction, Information Science, Instant Messaging, International Electro-Technical Commission (IEC), Laptop PC, Medical Equipment, Medical Products, Presentation/Verbal Skills, Product Development, Product Lifecycle Management, Quality Engineering, Regulations, Risk Analysis, Risk Management, Software Administration, Systems Engineering, Traceability, Usability Engineering, User Interface/Experience (UI/UX), Videoconferencing, Windchill PLM Software Iconma ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

• Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
• Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
• Founded in 2000
• 2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage. Company Size: 2,000 to 2,499 employees Industry: Management Consulting Services 2000 Website: https://www.iconma.com/