Staff R&D Engineer

About iRhythm:

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 seeking a Staff R&D Engineer to join our Product Development team. The Product Development team is made up of a close-knit group of talented engineers representing a wide range of engineering disciplines. This position is a hybrid role that will require you to be on-site in our San Francisco, California office, with flexibility for days of remote work as appropriate.

In this role, you will contribute directly to the development of wearable medical products, spanning early-stage research through commercialization. Our work environment is highly collaborative, and engineers at iRhythm work passionately to deliver innovative solutions that improve the quality of healthcare and the patient experience. We are looking for like-minded individuals to join our team!

Responsibilities

• Lead wear studies to evaluate various aspects of device performance
  • Author and review study protocols to obtain IRB approval for human subjects studies
  • Develop data collection procedures, case report forms, participant-facing materials, etc.
  • Work closely with Clinical Research team to design and execute studies
  • Conduct studies and maintain documentation according to Good Clinical Practice (GCP)
• Lead Verification & Validation (V&V) for new products and product changes:
  • Define overall test strategy
  • Develop and validate new test methods
  • Write test protocols and reports
  • Support deliverables for regulatory submissions
• Drive early-stage research to advance product innovation
  • Identify and evaluate promising technologies for incorporation into wearable sensing solutions
  • Develop highly user-focused designs that deliver high quality and reliable data insights (electro-mechanical sensor-based technologies)
  • Generate creative, scalable concepts that leverage thoughtfully chosen material choices that meet the needs of ambulatory, body-worn devices.
  • Ideate, test, and iterate on new concepts and processes
• Assess and prioritize technical activities for key development initiatives and early-stage feasibility work
• Translate clinical needs to engineering requirements and conversely, communicate technical concepts to non-technical people
• Analyze and interpret data through various techniques using Python or R
• Serve as subject matter expert in materials, biomechanics, and DOE (Design of Experiments)
• Contribute to generation of intellectual property
• Influence business and product decisions using research and data
• Offer daily technical guidance and mentorship to the ME team, with potential for future direct management responsibilities
  

About You:

You are interested in the intersection of technology and medicine and the evolving world of wearable sensors and digital health. As a versatile and well-rounded engineer, you can just as easily lead a cross-functional team to meet project milestones as roll up your sleeves for hands-on prototyping in the lab. You are a critical thinker who enjoys working on complex problems and feels comfortable exercising independent judgment. You must be able to juggle competing priorities and may supervise the activities of others.

Required Qualifications

• Degree in Biomedical Engineering, Mechanical Engineering, Materials Science Engineering, or similar discipline. PhD with 5+ years, MS with 8+ years, or BS with 10+ years of relevant experience in medical devices.
• Industry experience leading product development through the design control process and rigorous V&V test cycles in a highly regulated industry like medical devices
• Strong grasp of complex, hypothesis-driven experimental design
• Expertise in materials (e.g., adhesives, plastics, metals) and/or the relevant biomechanics of ambulatory, body-worn devices and the skin
• Knowledge of basic statistics
• Familiarity with physiological parameters and sensing (e.g. ECG, pulse oximetry, blood pressure)
• Self-motivated with an ability to work independently and to direct/manage the work of others as needed
• Demonstrated ability to communicate and collaborate effectively across engineering disciplines (e.g., Electrical, Quality, Manufacturing) and with cross-functional partners (e.g., Regulatory, Clinical Research)
• Values and prioritizes a supportive team environment that enables open-minded and respectful discussion
  

What’s in it for you: 

This is a full-time position with competitive salary package and excellent benefits including medical, dental and vision insurance, paid holidays and paid time off. 

iRhythm also provides additional benefits including 401K (w/ company match), an Employee Stock Purchase Plan, annual organizational/cultural committee events and more! 

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. 

Make iRhythm your path forward.