TN Visa Computer Systems Engineer Jobs
Computer Systems Engineer roles qualify for TN visa sponsorship under USMCA for Canadian and Mexican professionals with a degree in computer science, engineering, or a related field. Unlike H-1B visa, Canadians face no lottery or annual cap, making this one of the most direct paths to U.S. employment in systems-level engineering.
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Get Access To All JobsAbout CooperSurgical
JOB DESCRIPTION
CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions.
Work location: Trumbull, CT (on-site)
Scope:
The Senior Computer Systems Validation Engineer is responsible for validation of global computer systems, monitoring changes with regulations, and assists team members for CSI’s corporate CSV strategy to meet all applicable regulations.
Job Summary:
The Senior Computer Systems Validation Engineer provides strategic leadership and technical expertise for the validation, maintenance, and continuous improvement of computerized systems used in regulated environments. This role is responsible for establishing and maintaining the corporate CSV framework, overseeing critical programs and complex enterprise systems, ensuring regulatory inspection readiness, and driving a risk‑based, inspection‑ready validation culture across the organization.
Responsibilities
- Lead and guide Computer Systems Validation tasks and deliverables through enterprise and high‑risk programs throughout the systems life cycle.
- Propose streamlined approaches for CSV strategy and governance to meet compliance and usage of CSA.
- Ability to lead validation projects and/or validation tasks/phases of larger projects (including eQMS and Quality Systems).
- Drive inspection readiness and continuous improvement in CSV team.
- Train and mentor project team personnel (testers, business systems analysts) in computer systems lifecycle methodology.
- Work closely with IT, manufacturing, quality control, quality assurance, infrastructure, and other teams to provide guidance on CSV.
- Provide guidance with functional/end user requirements, compliance, and system specifications, and ensure proper documentation is maintained to drive operational excellence.
- Provide test execution training and assist teams with discrepancy management.
- Support process owners for quality management systems and associated policies, procedures, and work instructions.
- Oversee requirements traceability matrices for completeness of appropriate documentation and testing for user specific requirements. Review and identify critical issues.
- Ensure compliance with internal and external computer system lifecycle policies and regulations.
- Communicate effectively with users to identify needs and evaluate alternative business solutions with project/QA Operations/Quality Management/Regulatory/IT Compliance.
- Ensure issues are identified, tracked, reported, and resolved in a timely manner.
- Perform other duties as assigned.
Travel:
This position may require 5-10% domestic and/or foreign travel.
Qualifications
Knowledge, Skills and Abilities:
- Experience in Computer Systems Validation, Software Quality Assurance, and Quality Management Systems.
- Knowledge of Systems Delivery/Development Lifecycle Management (SDLC) and Change Management methodologies.
- Familiarity with computer systems used in support of GxP operations, and Computer System Validation documentation including CSV plans, requirements, risk assessments, test protocols (scripts), data migration plans/reports, traceability matrices, and summary reports.
- Experience and knowledge of various QMSs, Agile PLM, MasterControl, Veeva, TrackWise, or equivalent system.
- Knowledge of regulatory requirements including CSV, CSA, FDA 21 CFR Parts 11, 58, 211, 820, and 1271; GAMP, ISO 13485, and ISO 14971.
- Ability to effectively engage and collaborate with cross‑functional teams, including IT, Quality Assurance, Validation, and business project stakeholders.
- Knowledge of business enterprise functions and processes. Experienced in organizing meetings.
- Strong analytical and problem‑solving skills with ability to identify issues, evaluate options, and implement effective solutions.
- Ability to adapt to a fast and dynamic environment and effectively engage with various functional and technical teams.
- Skilled in developing, following, and maintaining procedures and supporting documentation to ensure compliance and consistency.
- Strong written, verbal, and interpersonal communication skills (ability to communicate effectively with all stakeholders).
- Effective time management skills with proven adaptability to shifting priorities, resource changes, and scheduling adjustments.
- Ability to work independently and within teams (collaborative environment); self‑motivated, self‑directed, and detail oriented.
- Proficiency with Microsoft Office, Microsoft D365, and Adobe Acrobat.
- Experience/knowledge of Agile PLM, MasterControl, IQVIA, or equivalent QMS system.
- Experience/knowledge of Waterfall, Agile, or Hybrid software development.
- Experience/knowledge of automated systems for following activities/functions is preferred:
- Enterprise Resource Planning (Oracle E Business Suite)
- Document management (SharePoint)
- Requirements and Testing (JIRA/Azure DevOps/HP ALM/HPQC)
- Change/Incident Management (ServiceNow)
- Project/Task Management (Smartsheet/Excel spreadsheets)
Work Environment:
- Prolonged periods of sitting, especially in front of a computer.
- Potential exposure to different manufacturing environments, necessitating adherence to varying safety protocols.
Experience:
- 7+ years of experience in assigned function's business process, engineering, and supporting systems for QA and Compliance departments.
- 5+ years of experience in Computer Systems Validation.
Education:
- Bachelor of Science Degree, Computer Engineering, or relevant science field required, or equivalent combination of education and experience.
Our Benefits:
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
About CooperSurgical
JOB DESCRIPTION
CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions.
Work location: Trumbull, CT (on-site)
Scope:
The Senior Computer Systems Validation Engineer is responsible for validation of global computer systems, monitoring changes with regulations, and assists team members for CSI’s corporate CSV strategy to meet all applicable regulations.
Job Summary:
The Senior Computer Systems Validation Engineer provides strategic leadership and technical expertise for the validation, maintenance, and continuous improvement of computerized systems used in regulated environments. This role is responsible for establishing and maintaining the corporate CSV framework, overseeing critical programs and complex enterprise systems, ensuring regulatory inspection readiness, and driving a risk‑based, inspection‑ready validation culture across the organization.
Responsibilities
- Lead and guide Computer Systems Validation tasks and deliverables through enterprise and high‑risk programs throughout the systems life cycle.
- Propose streamlined approaches for CSV strategy and governance to meet compliance and usage of CSA.
- Ability to lead validation projects and/or validation tasks/phases of larger projects (including eQMS and Quality Systems).
- Drive inspection readiness and continuous improvement in CSV team.
- Train and mentor project team personnel (testers, business systems analysts) in computer systems lifecycle methodology.
- Work closely with IT, manufacturing, quality control, quality assurance, infrastructure, and other teams to provide guidance on CSV.
- Provide guidance with functional/end user requirements, compliance, and system specifications, and ensure proper documentation is maintained to drive operational excellence.
- Provide test execution training and assist teams with discrepancy management.
- Support process owners for quality management systems and associated policies, procedures, and work instructions.
- Oversee requirements traceability matrices for completeness of appropriate documentation and testing for user specific requirements. Review and identify critical issues.
- Ensure compliance with internal and external computer system lifecycle policies and regulations.
- Communicate effectively with users to identify needs and evaluate alternative business solutions with project/QA Operations/Quality Management/Regulatory/IT Compliance.
- Ensure issues are identified, tracked, reported, and resolved in a timely manner.
- Perform other duties as assigned.
Travel:
This position may require 5-10% domestic and/or foreign travel.
Qualifications
Knowledge, Skills and Abilities:
- Experience in Computer Systems Validation, Software Quality Assurance, and Quality Management Systems.
- Knowledge of Systems Delivery/Development Lifecycle Management (SDLC) and Change Management methodologies.
- Familiarity with computer systems used in support of GxP operations, and Computer System Validation documentation including CSV plans, requirements, risk assessments, test protocols (scripts), data migration plans/reports, traceability matrices, and summary reports.
- Experience and knowledge of various QMSs, Agile PLM, MasterControl, Veeva, TrackWise, or equivalent system.
- Knowledge of regulatory requirements including CSV, CSA, FDA 21 CFR Parts 11, 58, 211, 820, and 1271; GAMP, ISO 13485, and ISO 14971.
- Ability to effectively engage and collaborate with cross‑functional teams, including IT, Quality Assurance, Validation, and business project stakeholders.
- Knowledge of business enterprise functions and processes. Experienced in organizing meetings.
- Strong analytical and problem‑solving skills with ability to identify issues, evaluate options, and implement effective solutions.
- Ability to adapt to a fast and dynamic environment and effectively engage with various functional and technical teams.
- Skilled in developing, following, and maintaining procedures and supporting documentation to ensure compliance and consistency.
- Strong written, verbal, and interpersonal communication skills (ability to communicate effectively with all stakeholders).
- Effective time management skills with proven adaptability to shifting priorities, resource changes, and scheduling adjustments.
- Ability to work independently and within teams (collaborative environment); self‑motivated, self‑directed, and detail oriented.
- Proficiency with Microsoft Office, Microsoft D365, and Adobe Acrobat.
- Experience/knowledge of Agile PLM, MasterControl, IQVIA, or equivalent QMS system.
- Experience/knowledge of Waterfall, Agile, or Hybrid software development.
- Experience/knowledge of automated systems for following activities/functions is preferred:
- Enterprise Resource Planning (Oracle E Business Suite)
- Document management (SharePoint)
- Requirements and Testing (JIRA/Azure DevOps/HP ALM/HPQC)
- Change/Incident Management (ServiceNow)
- Project/Task Management (Smartsheet/Excel spreadsheets)
Work Environment:
- Prolonged periods of sitting, especially in front of a computer.
- Potential exposure to different manufacturing environments, necessitating adherence to varying safety protocols.
Experience:
- 7+ years of experience in assigned function's business process, engineering, and supporting systems for QA and Compliance departments.
- 5+ years of experience in Computer Systems Validation.
Education:
- Bachelor of Science Degree, Computer Engineering, or relevant science field required, or equivalent combination of education and experience.
Our Benefits:
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
See all TN Visa Computer Systems Engineer Jobs
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Get Access To All JobsTips for Finding TN Visa Sponsorship as a Computer Systems Engineer
Align your credentials to specialty occupation standards
TN visa eligibility requires your degree to match the systems engineering work you'll perform. A software-focused degree supporting a hardware architecture role can trigger questions at the border, so document the technical overlap explicitly in your credential summary before applying.
Target employers with recent visa filings
Employers with recent visa filings for engineering roles already understand work visa sponsorship processes. Prioritize companies experienced with visa sponsorship in computer systems or related engineering roles to reduce friction in the offer stage.
Use Migrate Mate to find TN-ready Computer Systems Engineer roles
Search Migrate Mate to identify employers actively hiring Computer Systems Engineers with TN visa sponsorship. The platform filters roles by visa type so you're not guessing which employers will support the process.
Prepare a TN support letter before negotiating offers
Your employer's TN support letter must describe your role in terms that map directly to the USMCA Computer Systems Analyst category. Draft this language early so neither party is surprised by documentation requirements after you've accepted an offer.
Understand the Mexican TN allocation before your border appointment
Mexican citizens are subject to an annual TN allocation, unlike Canadians who can seek admission at any port of entry. Confirm your employer has accounted for this distinction when planning your start date and any USCIS filing timeline.
Carry project documentation to your port of entry inspection
CBP officers adjudicating TN applications for systems engineers sometimes request evidence that your actual duties are engineering-level, not general IT support. Bring a technical project summary or architecture diagram to demonstrate the specialized nature of your work.
Computer Systems Engineer TN Visa: Frequently Asked Questions
Does a Computer Systems Engineer role qualify for TN visa status?
Yes, provided the role maps to the Computer Systems Analyst category listed in the USMCA treaty schedule and requires at least a bachelor's degree in computer science, engineering, or a closely related field. The job title matters less than the actual duties. CBP will assess whether the position requires theoretical and practical application of specialized engineering knowledge, so your offer letter and support documentation need to reflect that standard.
How does TN compare to H-1B for Computer Systems Engineer positions?
TN has no annual lottery and no cap for Canadian citizens, which means you can apply at a port of entry or through USCIS without waiting for a random selection. H-1B requires employer sponsorship through a lottery that selects fewer than half of all registrants. For Mexican citizens, TN has an annual allocation, but it still avoids the lottery. TN status is also faster to obtain in most cases, though it does not provide a direct path to a green card the way H-1B can.
What documents does my employer need to provide for TN sponsorship?
Your employer must provide a support letter that details your job title, duties, required qualifications, intended length of employment, and the employer's agreement to the TN terms. For Computer Systems Engineer roles, the letter should explicitly connect your duties to systems-level engineering work rather than general software support. Your employer does not file a petition in advance for Canadian citizens, but Mexican citizens require a USCIS filing before the visa interview.
Can I find Computer Systems Engineer jobs that are already set up for TN sponsorship?
Migrate Mate lets you search specifically for Computer Systems Engineer roles where employers have indicated TN visa sponsorship. That saves you from cold-applying to companies unfamiliar with TN requirements and avoids situations where an employer withdraws support after an offer because they misunderstood the process.
What happens if my Computer Systems Engineer role involves mixed duties like management and engineering?
TN status requires that your primary duties qualify under the treaty's computer systems category. If management or administrative work makes up a substantial portion of your role, CBP may determine the position does not qualify. Ask your employer to structure the offer letter so that engineering responsibilities are clearly dominant, and avoid job titles like Engineering Manager that signal a shift away from direct technical work.