Staff Systems Engineer

Career-defining. Life-changing. 

At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

About This Role:

The Staff Systems Engineer will serve as the technical owner for a product line, spanning wearable biosensing devices, mobile applications, and cloud analytics. This role drives the product lifecycle end-to-end—from early concept and architecture through development, verification/validation, regulatory submissions (e.g., 510k), and design transfer into manufacturing. Post-market, the Staff Systems Engineer leads key technical investigations and improvements to ensure patient safety and product quality. Success in this role means making critical technical decisions, mentoring others, and delivering safe, innovative medical devices that help millions of patients receive timely diagnoses.

Essential Duties and Responsibilities:

• Translate user and business needs into clear system architectures, interfaces, and testable requirements.
• Own system design and documentation, inclusive of product requirements, system architecture design, technical reports, and trace matrices
• Contribute to regulatory submissions, author design history file (DHF) deliverables
• Lead post-market investigations, corrective and preventive actions (CAPA), and product improvements.
• Serve as system architect and decision authority for your product line, balancing safety, performance, cost, and schedule.
• Mentor engineers and influence across teams without direct authority.
• Represent Product Development on product core teams and communicate technical trade-offs to leadership and non-technical stakeholders.

Experience and Minimum Qualifications:

• 10+ years of experience in systems engineering or related field, preferably within the medical device industry or similarly regulated environments
• Bachelor’s, Master’s, or Ph.D. in Electrical, Biomedical, Systems, or related engineering field.
• Proven record of shipping regulated electro-mechanical products and contributing to regulatory submissions (e.g., 510k).

Knowledge, Skills and Abilities:

• Expertise in systems engineering across electrical, mechanical, firmware, and software/cloud interfaces.
• Demonstrated ability to lead architecture decisions and make clear trade-offs across performance, safety, cost, and schedule.
• Hands-on familiarity with circuit board schematic/layout, CAD drawings, and laboratory equipment.
• Proficiency with quality management and requirements/risk management tools (e.g., MasterControl, Jama) and bug tracking (Jira).
• Knowledge of FDA regulations and medical device standards: 21 CFR 820, ISO 13485, ISO 14971; familiarity with IEC 60601 and IEC 62304 preferred.
• Strong written and verbal communication, with a track record of aligning cross-functional teams under ambiguity.

Work Environment / Other Requirements:

• Hybrid role (3 days in office per week) based in San Francisco, CA.
• May require occasional travel to manufacturing sites, suppliers, or clinical sites.

What's In It For You

• Opportunity to impact millions of patients by bringing life-saving cardiac ambulatory monitoring technology to market.
• Ownership of an end-to-end product line and high visibility across the organization.
• Collaborative, mission-driven environment combining wearable biosensing, AI-enabled analytics, and healthcare innovation at scale.
• Competitive compensation, including base salary, annual bonus, and equity awards.
• Comprehensive benefits package with medical, dental, vision, 401(k) match, flexible PTO, and wellness programs

Location:

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

Estimated Pay Range

As a part of our core values, we ensure an 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 [email protected]

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.

There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact [email protected]. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.

For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121