TN Visa Staff Software Developer Jobs
Staff Software Developer roles qualify for TN visa sponsorship under the USMCA's Computer Systems Analyst category, which covers systems design, architecture, and software development work requiring a bachelor's degree in computer science or a related field. Canadian citizens can apply at the port of entry with no cap or lottery.
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Get Access To All JobsCareer-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:
The Staff Software Quality Engineer for Non-Product Software (NPS) will be the technical lead and subject matter expert (SME) responsible for the strategy, validation, and compliance of software tools used in the development and manufacturing of Medical Device.
This role ensures that all software applications supporting GxP business processes, software for tools and fixtures used for device manufacturing and processing, and software development/testing tools (e.g., Jira, Jenkins, GitHub) are validated according to the latest FDA Computer Software Assurance (CSA) guidance and ISO 13485 standards.
Essential Duties and Responsibilities:
- NPS Validation Strategy: Define and lead the Computer Software Assurance (CSA) strategy and validation master plans for new and existing non-product software.
- Risk Management: Apply risk-based testing methodologies to determine the appropriate rigor of validation for manufacturing, QMS, and development tools.
- Compliance Leadership: Ensure all NPS activities comply with 21 CFR Part 11 (electronic records/signatures) and ISO 13485.
- Documentation Oversight: Review, approve and occasionally author validation plans, software V&V, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols/reports.
- Tool Qualification: Lead the qualification of software-based test, manufacturing and processing equipment, automated data processing systems, and design tools.
- Cross-functional Collaboration: Partner with Manufacturing, IT, DevOps, and R&D teams to identify software needs and implement compliant workflows.
- Audit Readiness: Act as the technical lead for NPS during internal and external audits (FDA, ISO, Notified Bodies).
- Change Control: Manage software changes, updates, and patches via rigorous configuration management processes.
Experience and Minimum Qualifications:
Typically requires a minimum of 12 years of related experience with a Bachelor's degree in Computer Science, Biomedical Engineering, or related technical field; or 8 years and a Master's degree; or equivalent work experience.
Knowledge, Skills and Abilities:
- Regulatory Knowledge: Deep understanding of FDA 21 CFR Part 820, Part 11, IEC 62304 standards and GAMP5.
- NPS Expertise: Demonstrated experience with validating custom software, tools and fixtures for device manufacturing and processing, DevOps toolchains (e.g., Jira, Git), test automation, and/or GxP applications supporting QMS and other GxP business processes.
- Technical Skills: Experience implementing risk-based testing (CSA) and automated testing tools.
- Soft Skills: Proven ability to lead cross-functional projects, mentor junior engineers, and communicate complex compliance requirements to technical and non-technical stakeholders.
- Preferred skills: Experience with SaMD / AI-enabled medical devices.
Work Environment / Other Requirements:
- iOC based
- Hybrid role with a minimum of 3 days on site
Location:
Orange County
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
Estimated Pay Range
$127,000.00 - $165,000.00
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
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:
The Staff Software Quality Engineer for Non-Product Software (NPS) will be the technical lead and subject matter expert (SME) responsible for the strategy, validation, and compliance of software tools used in the development and manufacturing of Medical Device.
This role ensures that all software applications supporting GxP business processes, software for tools and fixtures used for device manufacturing and processing, and software development/testing tools (e.g., Jira, Jenkins, GitHub) are validated according to the latest FDA Computer Software Assurance (CSA) guidance and ISO 13485 standards.
Essential Duties and Responsibilities:
- NPS Validation Strategy: Define and lead the Computer Software Assurance (CSA) strategy and validation master plans for new and existing non-product software.
- Risk Management: Apply risk-based testing methodologies to determine the appropriate rigor of validation for manufacturing, QMS, and development tools.
- Compliance Leadership: Ensure all NPS activities comply with 21 CFR Part 11 (electronic records/signatures) and ISO 13485.
- Documentation Oversight: Review, approve and occasionally author validation plans, software V&V, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols/reports.
- Tool Qualification: Lead the qualification of software-based test, manufacturing and processing equipment, automated data processing systems, and design tools.
- Cross-functional Collaboration: Partner with Manufacturing, IT, DevOps, and R&D teams to identify software needs and implement compliant workflows.
- Audit Readiness: Act as the technical lead for NPS during internal and external audits (FDA, ISO, Notified Bodies).
- Change Control: Manage software changes, updates, and patches via rigorous configuration management processes.
Experience and Minimum Qualifications:
Typically requires a minimum of 12 years of related experience with a Bachelor's degree in Computer Science, Biomedical Engineering, or related technical field; or 8 years and a Master's degree; or equivalent work experience.
Knowledge, Skills and Abilities:
- Regulatory Knowledge: Deep understanding of FDA 21 CFR Part 820, Part 11, IEC 62304 standards and GAMP5.
- NPS Expertise: Demonstrated experience with validating custom software, tools and fixtures for device manufacturing and processing, DevOps toolchains (e.g., Jira, Git), test automation, and/or GxP applications supporting QMS and other GxP business processes.
- Technical Skills: Experience implementing risk-based testing (CSA) and automated testing tools.
- Soft Skills: Proven ability to lead cross-functional projects, mentor junior engineers, and communicate complex compliance requirements to technical and non-technical stakeholders.
- Preferred skills: Experience with SaMD / AI-enabled medical devices.
Work Environment / Other Requirements:
- iOC based
- Hybrid role with a minimum of 3 days on site
Location:
Orange County
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
Estimated Pay Range
$127,000.00 - $165,000.00
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
See all 548+ TN Visa Staff Software Developer Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new TN Visa Staff Software Developer Jobs.
Get Access To All JobsTips for Finding TN Visa Sponsorship as a Staff Software Developer
Align your credentials to the right TN category
Staff Software Developer roles must fit the Computer Systems Analyst TN visa category. Your degree must be in computer science, software engineering, or a directly related field. A general business or math degree alone will not satisfy CBP's specialty requirement for this job title.
Build a support letter that maps duties to TN criteria
Ask your employer to draft a support letter connecting your specific Staff Software Developer duties, such as system architecture, technical leadership, and software design, to the Computer Systems Analyst definition. Vague letters are the leading cause of CBP denials at the border.
Target employers who already file TN petitions regularly
Focus your search on companies with established TN and H-1B visa filing histories. These employers have HR and legal processes in place, which shortens the offer-to-start timeline. Use Migrate Mate to filter Staff Software Developer openings by employers with active visa sponsorship history.
Request a defined job title in your offer letter
Ensure your written offer uses a title that maps clearly to Computer Systems Analyst functions. A title like 'Staff Software Developer' is fine, but the letter must describe the role in terms of systems design and analysis. Generic titles such as 'Engineer' without qualifying language can trigger CBP questions.
Plan your Mexican TN timeline around consular capacity
Mexican nationals cannot seek TN admission at the port of entry and must schedule a consular interview. Book your appointment as soon as you have a signed offer letter, since wait times at U.S. consulates in Mexico vary significantly by city and season.
Prepare for CBP questions about dual-intent limitations
TN status does not permit dual intent, so CBP officers may ask about your immigration plans. Have a clear, truthful statement about your intent to work temporarily ready. Ongoing U.S. permanent residence applications can complicate TN admissions and should be discussed with an immigration attorney before your border crossing.
Staff Software Developer TN Visa: Frequently Asked Questions
Does a Staff Software Developer role qualify for TN visa sponsorship?
Yes, Staff Software Developer positions qualify under the TN visa's Computer Systems Analyst category, provided the role primarily involves systems design, architecture, and software analysis rather than purely manual coding tasks. Your employer's support letter must connect your specific duties to that category definition. CBP officers make the final determination at the port of entry for Canadian citizens, or at the consulate for Mexican nationals.
How does TN compare to H-1B for Staff Software Developer roles?
TN has no annual lottery and no cap for Canadian citizens, so you can start work as soon as CBP approves your application at the border. H-1B requires entering a lottery each spring with roughly a 25 percent selection rate. TN status renews indefinitely in three-year increments, but it does not permit dual intent, which matters if you plan to pursue a green card while working in the U.S.
Can I search for Staff Software Developer jobs that offer TN sponsorship on Migrate Mate?
Yes. Migrate Mate is built specifically for Canadian and Mexican professionals seeking U.S. roles with TN visa sponsorship. You can filter Staff Software Developer openings by employers who actively sponsor TN visas, which removes the uncertainty of approaching companies that may not understand or support the process.
What documents does my employer need to provide for my TN application as a software developer?
Your employer must provide a detailed support letter on company letterhead confirming your job title, a description of duties that aligns with the Computer Systems Analyst TN category, your anticipated start date, and your compensation terms. You bring that letter, your degree credentials, and your valid passport to the CBP port of entry if you're Canadian, or to your consular interview if you're Mexican.
What happens to my TN status if my employer is acquired or my role changes significantly?
A material change in employer, such as an acquisition that alters your legal employer of record, or a significant shift in job duties that moves away from systems analysis functions, can affect the validity of your TN status. Canadian citizens can seek a new TN admission at the port of entry with updated documentation. Mexican nationals should consult an immigration attorney before any role change to avoid a gap in authorized status.