Job Description

Boldly innovating to create trusted solutions that detect, predict, and prevent disease.

Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care...Join Us Now!

At iRhythm, we are dedicated, self-motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and committed to iRhythm's employees and the mission of the company. We are better together, embrace change and help one another. We are Thinking Bigger and Moving Faster.

About This Role

iRhythm's Product Development team is seeking an experienced Senior Human Factors Engineer to enhance product usability and safety through assessment and validation. You'll play a pivotal role within 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.

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.

Qualifications

• 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).
• Note: As part of your interview process, you may be asked to provide an example of HF documentation you have produced for an approved/released product.

Location: Remote or Hybrid (San Francisco)

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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Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range

$140,000$170,000 USD

As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com

About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm's vision is to deliver better data, better insights, and better health for all.

Make iRhythm your path forward. Zio, the heart monitor that changed the game.

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