About This Role

iRhythm's System Engineering team is seeking an experienced Human Factors Engineer to enhance product usability and safety through assessment and validation. You'll play a pivotal role in establishing iRhythm's Human Factors Center of Excellence, charting the course for the company's capabilities, and collaborating with cross-functional teams. This opportunity offers substantial career growth potential while positively impacting lives through design and technology.

Note: We are unable to offer any sort of sponsorship for this role.

Responsibilities

• Strategize, execute, and document usability engineering evaluations, including task analyses and human factors studies.
• Author formative and summative usability study protocols, and plan, coordinate, and moderate usability studies.
• Perform root cause analysis of use errors and aggregate data for presentations and formal reports.
• 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.

Qualifications

• BS/MS in Human Factors, or in a science/engineering discipline with relevant experience.
• 3-5 years of Human Factors experience in design-controlled processes, especially 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. Knowledge of relevant regulations and standards is a must.
• 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.
• Willing to work on-site at our San Francisco office (2-3 days a week) and be available for up to 25% travel, including both domestic and international trips (must be cleared for international travel).

Application Requirements

• Resume
• Optional: Example of HF documentation you have produced for an approved/released product.

What's In It For You

This is a regular full-time position with 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. Additionally, we offer:

• 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!

iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of Linked In Learning classes and so much more!

FLSA Status: Exempt

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