R&D Engineer Human Factors

Location: Fully Remote

Duties:

• Experienced R&D Engineer Human Factors to apply human factors and ergonomics expertise to the definition, design, and evaluation of products within the R&D division of Electrophysiology Systems, which is part of the Atrial Fibrillation business unit.
• Apply knowledge of human factors principles (human performance and limitations perceptual, cognitive, motor skills, anthropomorphic) and techniques (knowledge acquisition, user-interface design, usability evaluation) to cardiac electrophysiology systems product development.
• Organize and direct the work of staff and outside consultants working on human factors tasks to effectively and efficiently support product development efforts within the organization.
• Deliverables include but are not limited to: Usability engineering files; Task analyses; Usability risk analyses.
• Usability testing throughout the product development process, from formative testing of early prototypes through usability validation of final designs.
• Develop collaborative working relationships with other functions across the organization, including but not limited to the following: Work with regulatory affairs to develop strategies for new product submissions, create submission packages, and respond to questions from regulatory agencies.
• Work with design quality to ensure that the company’s usability engineering processes and methodologies meet and surpass the latest expectations of regulatory agencies and provide tangible value for our customers and our business.
• Keep abreast of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, ISO 14971, and the latest FDA guidance on applying human factors engineering) and advice management regarding potential improvements to internal processes and regulatory issues related to human factors engineering.
• Represent in meetings with regulatory agencies, at human factors professional meetings and conferences, and as a member of standards committees.
  
  

Requirements skills for the role:

• Requires in-depth knowledge and experience of human factors as well as cognitive psychology theory and application; the software development process, software technology, and effective methods of working with R&D teams; customers, trends, governmental factors and emerging research and technologies affecting product usability.
• A qualified record of implementing new processes to existing human factors and related systems.
• Documented record of delivering software engineering information which adds value to management’s decision-making process.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to travel approximately 10%, including internationally.
  
  

Qualifications:

• 5 years related experience.
• Bachelor’ Degree in Human Factors Engineering, Experimental Psychology, Cognitive Psychology, Industrial Design, or a related field.
  
  

Preferred qualifications:

• Experience working on U.S. Food and Drug Administration (FDA) regulated, class 2 or class 3 medical devices or combination.
• Knowledge of insulin-requiring diabetes / strong diabetes disease state and diabetes product knowledge.
• Understanding of Quality System Regulations (QSR), including maintenance of a Design History File (DHF)/Usability Engineering File.
• Strong interpersonal and communication skills in both written and verbal form.
  
  

As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.