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

ICONMA

Role overview

Qualifications

  • BS in Human Factors Engineering, Biomedical Science or Engineering, Systems Engineering, Quality Engineering, Information and Data Science, Cognitive Psychology, Computer Science with HCI emphasis, Human Centered Design, or related field.
  • Minimum of 5 years of related experience with design controls, risk remediation, and risk analysis in medical device product development.
  • Experience with Digital project collaboration tools (e.g. Polarion, Agile PDM, Smartsheets).
  • Background in MDR regulations and human factors best practices for medical devices.

Responsibilities

  • Support remediation of usability related risk analysis documentation, including revising, editing, and reformatting.
  • Support definition, release, and maintenance of usability related design inputs documentation.
  • Create and maintain tracing documentation to identify and resolve tracing conflicts and design input orphans.
  • Use client laptop, software, and administrative systems.

About the company

ICONMA logo

ICONMA

Management Consulting

We provide Professional Staffing Services & Project-Based Solutions for a broad range of Fortune 500 organizations. ICONMA is a certified Woman-Owned staffing company and was founded in 2000. ICONMA’s corporate headquarters is in Troy, Michigan, and has 15+ locations worldwide. What makes ICONMA stand out in a fiercely competitive industry? *We provide integrated, full lifecycle services across a broad range of business and technical platforms. *No single company can duplicate our full range of staffing and permanent recruiting services nationwide. *Proven track record of attracting and retaining exceedingly skilled professional workers in a highly competitive market. SERVICES OFFERED Staff Augmentation (Contract, Contract to Hire, Direct Hire, Single Source) Data Analysis Project-Based Services & Solutions Hire Train Deploy Service Model Offshore Staff Augmentation Payroll Services AREAS OF EXPERTISE - Information Technology - Engineering - Business Professional - Accounting/Finance - Admin/Clerical/Call Center - Healthcare/Clinical/Scientific - Marketing/Creative mail linkedin@iconma.com Phone (888) 451-2519 Website http://www.iconma.com

Company details

Company typeLarge
IndustryManagement Consulting
Company size1001 - 5000

Links

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Job description

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.
 
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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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