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Senior Human Factors Engineer-Medical Devices
2 months ago
**This position is hybrid at our facility in San Francisco, CA** 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 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. This role will work remote from a US based home office. 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. 5 years of Human Factors experience in design-controlled processes in the medical device space. 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. Available for occasional travel as needed, 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
