[Remote] Staff Software Engineer, Manufacturing Cybersecurity (Medical Devices)
Note: The job is a remote job and is open to candidates in USA. iRhythm Technologies, Inc. is a leading digital healthcare company that creates trusted solutions for cardiac health. The Staff Software Engineer will design and develop secure software for manufacturing tools and fixtures used in cardiac monitoring devices, ensuring compliance with cybersecurity standards throughout the software development lifecycle.
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, ISO 13485 and ISO/IEC 27001
• 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
Skills
• 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
• 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)
• 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
• Experience with Python or other scripting languages for automation or integration tasks
• 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
• Familiarity with software QA processes in regulated environments (e.g., medical device, FAA, SEC, DoD, Title 21 CFR Part 11) is preferred
• CISSP, CEH, CSSLP, or equivalent security certification
• Experience with secure development lifecycle or threat modeling frameworks such as STRIDE or OWASP
Benefits
• Medical, dental, and vision insurance (all of which start on your first day)
• Paid holidays
• PTO
Company Overview
• iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease. It was founded in 2006, and is headquartered in San Francisco, California, USA, with a workforce of 1001-5000 employees. Its website is http://www.irhythmtech.com.
Company H1B Sponsorship
• iRhythm Technologies, Inc. has a track record of offering H1B sponsorships, with 9 in 2025, 13 in 2024, 10 in 2023, 9 in 2022, 16 in 2021, 11 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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