Staff Software Engineer – Manufacturing Software (Medical Devices)

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:

Key Responsibilities:

• Design and develop secure, high-quality C# software for manufacturing tools and fixtures used in the production of our Cardiac monitoring devices.
• Lead the design, implementation and documentation of secure software systems that support manufacturing and production processes for medical devices.
• 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.
• Collaborate with manufacturing engineering, IT/OT teams, quality, and regulatory functions to ensure that production software systems meet both operational and security requirements.
• Develop and maintain secure interfaces between manufacturing equipment and other enterprise systems.
• Support compliance with medical device and cybersecurity standards, including FDA Premarket Cybersecurity Guidance, ISO/IEC 81001-5-1, IEC 62304, and ISO 13485.
• Guide and mentor development teams on secure coding principles, risk mitigation, and compliance with cybersecurity standards.
• Support verification and validation activities, including documentation aligned with medical device regulatory frameworks
• Investigate and resolve complex security and performance issues across the manufacturing software stack.
• Contribute to continuous improvement initiatives and champion a culture of “doing things right the first time” while maintaining delivery velocity.

Qualifications:

• Education:
  • Bachelor’s degree in Computer Science, Computer Engineering, Electrical Engineering, or a related field with 12+ years of relevant industry experience, OR
  • Master’s degree in a related field with 8+ years of experience.
• Experience:
  • Minimum 2+ years with a security-focused role or equivalent hands-on experience implementing secure systems.
  • Strong programming skills in C# or a similar modern object-oriented programming language.
  • Familiarity with software QA processes in regulated environments (e.g., medical device, FAA, SEC, DoD, Title 21 CFR Part 11) is preferred.
  • Experience with low-level embedded serial communication protocols such as UART, and USB. 
  • Strong knowledge of secure coding practices, authentication/authorization mechanisms, encryption standards, and vulnerability management.
  • Experience with industrial network security, OT cybersecurity, or IT/OT system integration is highly desirable.
  • Experience with Python or other scripting languages for automation or integration tasks is a plus.
     

Core Attributes:

• Strong analytical and problem-solving skills with a detail-oriented mindset.
• Demonstrated ability to balance speed and quality, caring as much about doing things right as getting things done.
• Excellent communication skills and ability to influence across multidisciplinary teams.
• Proven leadership in mentoring and fostering secure software development practices.
   

Preferred Certifications (Nice to Have):

• CISSP, CEH, CSSLP, or equivalent security certification.
• Experience with secure development lifecycle or threat modeling frameworks such as STRIDE or OWASP.
   

What’s in it for you: 

• This is a full-time position with a competitive compensation package, excellent benefits, including medical, dental, and vision insurance (all of which start on your first day), paid holidays, and PTO. 

Location:

San Francisco

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

Estimated Pay Range

$185,000.00 - $240