iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias are clinically diagnosed by combining our wearable bio sensing technology with powerful cloud-based data analytics and Artificial Intelligence capabilities. Our goal is to be the leading provider of ambulatory ECG monitoring for patients at risk for arrhythmias. iRhythm's continuous ambulatory monitoring has already put over 4 million patients and their doctors on a shorter path to what they both need - answers.
About this role:
iRhythm is currently seeking an experienced Sr. Human Factors Engineer. Our work environment is fast-paced, with a collaborative atmosphere. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient experience. We are looking for like-minded individuals to join our team today!
Specific job responsibilities include:
• Strategize, execute, and document formative study evaluation which may include but are not limited to heuristic evaluation, expert review, simulated use studies, and actual use studies
• Work closely with other Verification & Validation (V&V) teams during Design Validation and Summative Human Factors Validation
• Partner with quality teams to stay abreast of complaints from on-market products for usability-related issues
• Collaborate with product designers and/or 3rd party vendors for packaging and other industrial design needs.
• Coordinate with Manufacturing and Operations to ensure viability and execution of product packaging strategies
• Minimum 5+ years of experience evaluating and documenting HF within design-controlled processes, preferably in the medical device or other highly regulated domain.
• Experience working cross-functionally on risk management activities
• Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidance for medical devices and combinations products
• Fully versed in FDA's Guidance for Applying Human Factors and Usability Engineering to Medical Devices, HE75, and IEC 62366-1, -2
• Ability to communicate effectively: Verbal and presentation skills as well as excellent writing skills.
• Strong interpersonal skills and the ability to collaborate actively and proactively with others in a cross-functional team
• Experience managing 3rd party vendors
• Bachelor's/Master's in Human Factors, Psychology, Anthropology, Cognitive Science, or related field.
• Willing to travel up to 15% of the time (post COVID).
What's in it for you:
This is a full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurance (all of which start on your first day), paid holidays, and PTO!
iRhythm also provides additional benefits including 401K (with company match), an Employee Stock Purchase Plan, paid parental leave, pet insurance discount, Cultural Committee/Charity events, and so much more!
FLSA Status: Exempt
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 (M/F/V/D). Pursuant to San Francisco Fair Chance Ordinance, we will consider for employment all qualified applicants with arrest and conviction records.