Staff Software Engineer – Manufacturing Software (Medical Devices) at iRhythm Technologies

San Francisco, California, United States

iRhythm Technologies Logo
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, HealthcareIndustries

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
  • Strong knowledge of secure coding practices, authentication/authorization mechanisms, encryption standards, and vulnerability management
  • Experience with low-level embedded serial communication protocols such as UART, and USB
  • 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
  • Experience with Python or other scripting languages for automation or integration tasks is a plus
  • 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

Responsibilities

  • Design and develop secure, high-quality C# software for manufacturing tools and fixtures used in the production of 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

Skills

C#
Cybersecurity
NIST SP 800
MFA
Cryptography
IEC 62304
ISO 13485
Secure Coding
SDLC
Code Review
Vulnerability Assessment
FDA Cybersecurity

iRhythm Technologies

Advanced cardiac monitoring solutions provider

About iRhythm Technologies

iRhythm Technologies focuses on cardiac monitoring solutions, with its main product being the Zio Patch, a wearable device that tracks heart rhythms for up to 14 days. This extended monitoring helps healthcare providers detect irregular heart rhythms that shorter monitoring might miss, making it especially useful for patients at risk. The company serves both patients and healthcare providers, generating revenue by selling the Zio Patch and offering data analysis services to interpret the collected heart data. iRhythm aims to improve patient outcomes and streamline healthcare workflows in the cardiac health sector.

San Francisco, CaliforniaHeadquarters
2006Year Founded
$102.8MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
1,001-5,000Employees

Benefits

Health Insurance
Dental Insurance
Vision Insurance
Health Savings Account/Flexible Spending Account
Unlimited Paid Time Off
Paid Vacation
Paid Holidays
401(k) Retirement Plan
401(k) Company Match
Employee Stock Purchase Plan
Mental Health Support
Hybrid Work Options
Pet Insurance

Risks

Increased competition from emerging cardiac monitoring technologies threatens market share.
FDA warning letter may lead to regulatory scrutiny and potential fines.
Shareholder investigation could result in legal challenges and financial liabilities.

Differentiation

Zio Patch offers up to 14 days of uninterrupted cardiac monitoring.
iRhythm's Zio Patch is the smallest and least conspicuous cardiac diagnostic device.
The company provides data analysis services for actionable insights from Zio Patch data.

Upsides

Wearable health tech market growth aligns with iRhythm's business model.
Telehealth expansion increases demand for remote monitoring solutions like Zio Patch.
AI integration enhances arrhythmia detection accuracy in iRhythm's Zio Patch.

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