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.

• 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).

• 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.

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

• 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