Software Development Engineer II; LCE

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

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.

• 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…