Staff Software Engineer, Manufacturing Cybersecurity (Medical Devices)

iRhythm Technologies, Inc.

Job Overview

Location

Indiana, USA

Job Type

Full-time

Full Job Description

📋 Description

• Embark on a career-defining journey as a Staff Software Engineer, Manufacturing Cybersecurity at iRhythm Technologies, a leader in digital healthcare dedicated to improving cardiac health solutions globally. This role offers a unique opportunity to leverage your expertise in secure software development to directly impact the production of life-changing medical devices, shaping both the future of cardiac care and your own professional growth.
• You will be instrumental in designing, developing, and implementing secure, high-quality C# software solutions for the critical manufacturing tools and fixtures that underpin the production of iRhythm's innovative cardiac monitoring devices. This involves taking ownership of the entire software lifecycle, from initial concept and design through to deployment and ongoing maintenance, ensuring robust security and operational excellence at every stage.
• A core aspect of this position is defining and rigorously enforcing cybersecurity best practices across the manufacturing software development lifecycle (SDLC). This includes conducting thorough code reviews, performing vulnerability assessments, and actively participating in the threat modeling process to proactively identify and mitigate potential risks before they can impact production.
• You will be expected to possess and apply a strong understanding of NIST SP 800-series security controls, with a particular focus on implementing robust security measures such as Multi-Factor Authentication (MFA), comprehensive identity management solutions, and industry-leading cryptographic best practices to safeguard sensitive manufacturing data and systems.
• Collaboration is key in this role. You will work closely with cross-functional teams, including manufacturing engineering, IT/OT (Information Technology/Operational Technology) specialists, quality assurance, and regulatory affairs. This collaborative approach ensures that all production software systems not only meet stringent operational requirements but also adhere to the highest cybersecurity standards, maintaining compliance and integrity.
• A significant responsibility will be the development and maintenance of secure, reliable interfaces between diverse manufacturing equipment and other enterprise systems. This requires a deep understanding of system integration and the ability to implement secure data exchange protocols, ensuring seamless and protected communication across the manufacturing ecosystem.
• You will play a vital role in supporting iRhythm's commitment to compliance with critical medical device and cybersecurity standards. This includes adherence to regulations and guidelines such as FDA Premarket Cybersecurity Guidance, ISO/IEC 81001-5-1, IEC 62304, ISO 13485, and ISO/IEC 27001, ensuring that all software developed meets the rigorous demands of the healthcare industry.
• As a Staff Engineer, you will be a technical leader, guiding and mentoring development teams on secure coding principles, effective risk mitigation strategies, and the practical application of cybersecurity standards within the medical device context. Your leadership will foster a culture of security consciousness throughout the engineering organization.
• You will actively support verification and validation (V&V) activities, ensuring that all documentation is meticulously prepared and aligned with the complex requirements of medical device regulatory frameworks. This includes contributing to the creation of robust V&V plans and reports.
• This role demands the ability to investigate and resolve complex security and performance issues that may arise across the manufacturing software stack. Your analytical skills and deep technical knowledge will be crucial in troubleshooting and implementing effective solutions to maintain system stability and security.
• You will be a champion for continuous improvement, actively contributing to initiatives aimed at enhancing software quality, development processes, and cybersecurity posture. You will embody and promote a culture of “doing things right the first time” while maintaining the necessary delivery velocity to meet business objectives.
• This position is ideal for a curious and innovative problem solver who is passionate about building secure, high-impact software within a regulated industry and is looking for an opportunity to make a meaningful difference in patient lives and advance their career in a dynamic and growing company.

🎯 Requirements

• 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) is preferred.
• Experience with industrial network security, OT cybersecurity, or IT/OT system integration is highly desirable.
• Strong knowledge of secure coding practices, authentication/authorization mechanisms, encryption standards, and vulnerability management.

🏖️ Benefits

• Competitive compensation package with an estimated pay range of $185,000 - $240,000.
• Comprehensive benefits package including medical, dental, and vision insurance, all starting on your first day of employment.
• Paid holidays and Paid Time Off (PTO) to support work-life balance.
• Opportunity to work remotely within the US, offering flexibility and convenience.
• Career growth and development opportunities within a leading digital healthcare company.

Skills & Technologies

Python

Senior

Remote

$185k-240k

Degree Required

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iRhythm Technologies, Inc.

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About iRhythm Technologies, Inc.

iRhythm Technologies, Inc. provides FDA-cleared cardiac monitoring solutions that use wearable biosensor technology and cloud-based data analytics to detect arrhythmias. The Zio patch records continuous ECG for up to 14 days, while proprietary algorithms analyze millions of heartbeat data points to generate clinical reports for physicians. The company serves hospitals, clinics, and healthcare systems aiming to improve diagnostic accuracy and reduce stroke risk associated with undiagnosed atrial fibrillation.

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