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

San Francisco, California, United States

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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

Key technologies and capabilities for this role

C#CybersecurityNIST SP 800MFACryptographyIEC 62304ISO 13485Secure CodingSDLCCode ReviewVulnerability AssessmentFDA Cybersecurity

Questions & Answers

Common questions about this position

What experience level is required for this Staff Software Engineer role?

A Bachelor’s degree in Computer Science, Computer Engineering, Electrical Engineering, or a related field with 12+ years of relevant industry experience, or a Master’s degree in a related field with 8+ years of experience is required. Minimum 2+ years with a security-focused role or equivalent hands-on experience implementing secure systems is also needed.

What programming skills are required for this position?

Strong programming skills in C# or a similar modern object-oriented programming language are required. Experience with low-level embedded serial communication protocols such as UART, and USB is also needed.

What is the salary or compensation for this role?

This information is not specified in the job description.

Is this a remote position or does it require on-site work?

This information is not specified in the job description.

What makes a strong candidate for this Staff Software Engineer role?

Candidates with a relevant degree and 8-12+ years of experience, strong C# programming skills, security-focused experience, familiarity with regulated environments like medical devices, and knowledge of embedded protocols will stand out. Experience supporting compliance with standards like FDA guidance and ISO 13485 is preferred.

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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