Irhythm Technologies, Inc

In this role, you’ll ensure product usability and safety through assessment and validation while collaborating with cross-functional engineering groups, product design, product management, and other functions to help define the future of our Zio platform.. Works 2-3 days a week in our SFB office and the remainder at home.. Collaborate with design teams throughout the design cycle to identify opportunities for creating designs that are both patient-centric and compliant with FDA guidance for Human Factors.. 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!. Make iRhythm your path forward.

human factors engineer

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 We are seeking an experienced Human Factors Engineer who is passionate about improving people's lives through design and technology. In this role, you’ll ensure product usability and safety through assessment and validation while collaborating with cross-functional engineering groups, product design, product management, and other functions to help define the future of our Zio platform. NOTE: This role is Hybrid. Works 2-3 days a week in our SFB office and the remainder at home. We are unable to offer any sort of sponsorship for this role. Responsibilities Include <ul><li>Strategize, execute, and document formative study evaluations which may include but are not limited to heuristic evaluation, expert review, simulated use studies, and actual use studies.</li><li>Work closely with other Verification & Validation (V&V) teams during Design Validation and Summative Human Factors Validation.</li><li>Partner with quality teams to stay abreast of complaints from on-market products for usability-related issues.</li><li>Collaborate with design teams throughout the design cycle to identify opportunities for creating designs that are both patient-centric and compliant with FDA guidance for Human Factors. </li></ul>Requirements <ul><li>Minimum 5+ years of experience evaluating and documenting HF within design-controlled processes, preferably in the medical device or other highly regulated domain.</li><li>Experience working cross-functionally on risk management activities.</li><li>Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidance for medical devices and combination products.</li><li>Fully versed in FDA’s Guidance for Applying Human Factors and Usability Engineering to Medical Devices, HE75, and IEC 62366-1, -2.</li><li>Experience with failure mode analysis (FMEAs) and risk management.</li><li>Ability to communicate effectively: Verbal and presentation skills as well as excellent writing skills.</li><li>Strong interpersonal skills and the ability to collaborate actively and proactively with others in a cross-functional team.</li><li>Experience managing 3rd party vendors.</li><li>Bachelor’s/Master’s in Human Factors or related field.</li><li>Willing to travel up to 15% of the time. </li></ul>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: <ul><li>emotional health support for you and your loved ones</li><li>legal / financial / identity theft/ pet and child referral assistance</li><li>paid parental leave, paid holidays, travel assistance for personal trips and PTO! </li></ul>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 Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location. Estimated Pay Range $143,800—$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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