Telecommute Polarion Jobs (NOW HIRING)

• Minimum of 5+ years of related experience with a bachelor s degree in engineering.
• Experience with design controls, risk remediation, and risk analysis related to medical device product development or a related field.
• Experience working with digital project collaboration tools such as Polarion, Agile, or Smartsheets.
• Background and understanding of MDR regulations and best practices for medical device human factors including IEC 62366, AAMI HE75, and FDA guidance on Applying Human Factors and Usability Engineering to Medical Devices.
• Excellent communication and presentation skills.
• Ability to communicate effectively with stakeholders within a highly structured environment using multiple communication channels.

• Support remediation of usability related risk analysis documentation, including revising, editing, 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 within the Polarion tracing environment to identify and resolve tracing conflicts and design input orphans in tracing between risks and design inputs/risk controls.
• Inform, guide development of, and maintain usability engineering documentation produced during product development projects.
• Implement comprehensive and timely task analysis and related risk analysis documents.
• Support the Human Factors Engineering team with expertise in design controls and content creation in tools such as Polarion and document control software.

• Human Factors.
• Design Controls.
• Risk Analysis.
• Polarion.
• Medical Device Regulations.
• Agile.
• Smartsheets.
• Usability Engineering.

• 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.

===

• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities