Software Development Engineer II (Lifecycle Engineering)

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:

iRhythm’s Product Development team is seeking a highly skilled Software Development Engineer to join our Lifecycle (Sustaining) Engineering team. This role focuses on supporting existing products through their lifecycle, ensuring quality, compliance, and continuous improvement while maintaining business continuity. In this role, you will own and execute product tooling/fixturing software (C#) changes that keep our released medical device products safe, compliant, manufacturable, and reliable. You’ll work closely with our product development team of embedded firmware and C# software engineers and cross-functionally with hardware, quality, and operations to resolve field and factory issues, manage obsolescence, improve yield, and maintain regulatory compliance. This opportunity offers substantial career growth potential while positively impacting lives through design and technology.

Responsibilities

• Design and develop C# software updates to manufacturing test systems (fixture software, functional test scripts, ICT/boundary scan integration) and drive improvements to yield, throughput, and reliability.
• Own software changes across released manufacturing test fixtures including bug fixes, minor feature enhancements, refactors, and obsolescence-driven updates working within established design controls and change management processes.
• Define and enforce cybersecurity best practices throughout the manufacturing software development lifecycle (SDLC), including code reviews, and vulnerability assessments.
• Familiarity with NIST SP 800-series security controls for software design, including the implementation of Multi-Factor Authentication (MFA), identity management, and cryptographic best practices.
• Contribute to secure product maintenance by assessing and implementing vulnerability patches, managing third‑party dependencies current in line with evolving guidance.
• Maintain configuration management (requirements, code, test assets, DHF/DMR updates, SBOMs), ensuring complete documentation and traceability through release.
• Lead software investigations for field returns, NCRs, and deviations; perform structured root cause analysis; implement and verify CAPA actions with clear traceability.
• Perform software risk management activities (ISO 14971), update hazard analyses, perform impact assessments for changes, and ensure risk controls remain effective post-change.
• Collaborate cross-functionally with Hardware, Quality, Regulatory, Manufacturing, Supply Chain, and external suppliers/CMs to plan and execute changes with minimal disruption.

Minimum Qualifications

• BS in Computer Engineering, Computer Science, or related field
• 2+ years’ experience in software development (C#).
• Strong programming skills in C# or a similar modern object-oriented programming language.
• Strong understanding of FDA QSR, ISO 13485, IEC 60601, ISO 14971 and IEC 62304 standards.
• Familiarity with software QA processes in regulated environments (e.g., medical device, FAA, SEC, DoD, Title 21 CFR Part 11) is preferred.
• Experience with Python or other scripting languages for automation or integration tasks is a plus.
• Cybersecurity for medical devices experience (SBOM management, vulnerability assessment, third party component governance) is a plus.

Location: On-site (Cypress, CA – Orange County)

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