TN Visa Staff Software Engineer Jobs
Staff Software Engineer roles qualify for TN visa sponsorship under the USMCA's 'Computer Systems Analyst' category, covering senior IC and tech lead positions at U.S. employers. Canadians enter without a cap or lottery. Mexican nationals use the TN allocation. Your bachelor's degree in computer science or a related field is the core credential officers assess.
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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 Engineer Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new TN Visa Staff Software Engineer Jobs.
Get Access To All JobsTips for Finding TN Visa Sponsorship as a Staff Software Engineer
Frame your credentials around the TN category
Staff Software Engineer sits under the 'Computer Systems Analyst' TN visa category. Your degree and offer letter must explicitly connect to systems analysis or software engineering, not generic 'technology.' Mismatched framing is the most common TN denial trigger for this role.
Target employers experienced with visa sponsorship
Not every company that posts Staff Engineer roles has experience with visa sponsorship. Prioritize employers with recent visa filings, so you're not educating legal counsel from scratch during offer negotiations.
Negotiate the offer letter before signing anything
Your TN support letter is the single document CBP scrutinizes most. Get your employer to specify your proffered wage, the systems you'll analyze, and your reporting structure in the offer letter before any paperwork is submitted.
Prepare for port-of-entry TN processing as a Canadian
Canadians can obtain TN status directly at a land port or airport preclearance without consular appointment. Bring your offer letter, degree transcripts, and resume. Officers may ask detailed technical questions about your Staff Engineer scope, so rehearse concise answers.
Use Migrate Mate to find TN-eligible staff engineer roles
Search Migrate Mate to identify Staff Software Engineer openings at employers with recent visa filings. Filtering by roles that typically qualify for TN status helps you focus on companies experienced with sponsoring work visas.
Understand the Mexican TN process before accepting an offer
Mexican nationals must apply at a U.S. consulate rather than a port of entry. Build at least four to six weeks into your start-date negotiation to account for consular scheduling, and confirm your employer's legal team has handled consular TN filings specifically.
Staff Software Engineer TN Visa: Frequently Asked Questions
Does a Staff Software Engineer role qualify for a TN visa?
Yes, provided the role is framed correctly. Staff Software Engineer positions qualify under the USMCA's 'Computer Systems Analyst' professional category. The offer letter must describe duties involving systems analysis, design, and software architecture. A generic 'software engineer' description without that systems-analysis framing can trigger a denial at the port of entry or consulate.
How does the TN visa compare to H-1B for Staff Software Engineer roles?
The TN has no annual lottery, no cap for Canadian citizens, and no six-year maximum stay, making it significantly more predictable for senior engineering roles. H-1B visa selection is lottery-based and can take years to secure. The trade-off is that TN status is employer-specific and requires a direct qualifying job offer tied to the USMCA category each time you file.
Where can I find Staff Software Engineer jobs with TN visa sponsorship?
Migrate Mate is built specifically for Canadian and Mexican professionals seeking TN-eligible roles in the U.S. You can search Staff Software Engineer openings filtered by employers already set up to sponsor TN status, which removes the guesswork of cold-screening companies unfamiliar with the USMCA visa category.
What documents do I need to apply for TN status as a Staff Software Engineer?
You need a detailed employer support letter specifying your job duties, proffered wage, and employment period; proof of Canadian or Mexican citizenship; and academic credentials confirming a bachelor's degree in computer science, engineering, or a directly related field. Canadian citizens also bring a resume and may be asked technical questions by CBP officers at the port of entry.
Can I switch employers while on TN status as a Staff Software Engineer?
Yes, but TN status is employer-specific. You must secure a new offer letter from the incoming employer and obtain new TN authorization before your start date. Canadian citizens can do this at a port of entry. Mexican nationals need a new consular appointment. There is no formal grace period coded into TN status the way H-1B portability provisions work, so timing matters.