Senior Human Factors Engineer I

Summary

Join iRhythm's Product Development team as a Senior Human Factors Engineer and enhance product usability and safety. You will be a pivotal member of the Human Factors Center of Excellence, collaborating with cross-functional teams to chart the course for the company's capabilities. This role offers significant career growth and the opportunity to positively impact lives through design and technology. Responsibilities include conducting usability evaluations, authoring study protocols, performing root cause analyses, and collaborating with various teams. The ideal candidate possesses a BS in Human Factors or a related field with 5+ years of experience in regulated domains like medical devices. iRhythm offers a competitive compensation package, excellent benefits, and a supportive work environment.

Requirements

• BS in Human Factors, or in a science/engineering discipline with relevant experience required; advanced degree a plus
• 5+ years of Human Factors experience in design-controlled processes, specifically in regulated domains like medical devices
• Must understand regulatory requirements, possess strong knowledge of medical device design and FDA guidelines, and be familiar with HE75 and IEC 62366-1, -2
• Cross-functional experience in risk management activities, including FMEA expertise
• Proficient in leading Human Factors processes, including study design, moderation, and execution
• Skilled in deriving conclusions from study data and conducting effective root cause analyses
• Demonstration of exceptional technical problem-solving, interpersonal, and communication skills (verbal and written)
• Experience managing 3rd party vendors
• Available for up to 25% travel, including both domestic and international trips (must be cleared for international travel)

Responsibilities

• Strategize, execute, and document usability engineering evaluations, including task analyses and human factors studies
• Author formative and summative usability study protocols
• Plan, coordinate, and moderate formative and summative usability studies
• Perform root cause analysis of use errors and aggregate data for presentations and formal reports
• Partner with external vendors as required to execute of human factors evaluations (recruiting, study design, execution, analysis, & reporting)
• Author and update usability risk analyses in collaboration with cross-functional stakeholders
• Collaborate with Verification & Validation (V&V) teams during Design Validation and Summative Human Factors Validation
• Partner with Quality teams to address complaints related to usability on-market products
• Work with design teams to create patient-centric and compliant designs
• Assist in developing usability engineering processes for Quality system improvements
• Support inquiries, audits, and discussions with regulatory agencies

Preferred Qualifications

Advanced degree

Benefits

• Competitive compensation package
• Excellent benefits including medical, dental, and vision insurances (all of which start on your first day)
• Health savings account employer contributions (when enrolled in high deductible medical plan)
• Cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts)
• Travel reimbursement for medical care
• Noncontributory basic life insurance & short/ long term disability
• Emotional health support for you and your loved ones
• Legal / financial / identity theft/ pet and child referral assistance
• Paid parental leave
• Paid holidays
• Travel assistance for personal trips and PTO!
• 401(k) (with company match)
• An Employee Stock Purchase Plan
• Pet insurance discount
• Unlimited amount of Linked In Learning classes