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:

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 taops@irhythmtech.com

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 taops@irhythmtech.com. 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