Green Card Software Design Engineer Jobs
Software Design Engineer roles consistently qualify for EB-2 and EB-3 green card sponsorship through the PERM labor certification process, which requires your employer to document that no equally qualified U.S. worker is available. Most positions need a bachelor's degree in computer science or a related engineering field, and sponsorship timelines vary significantly by country of birth.
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Get Access To All JobsPosition Summary
The Senior Software Design Quality Engineer serves as a senior Design Quality authority for software-enabled in-vitro diagnostics (IVD) medical devices across the development lifecycle. This includes software-enabled diagnostic systems incorporating image analysis and AI/ML-based algorithms to support detection and classification of cellular abnormalities. Embedded on New Product Development (NPD) core teams, this role owns software design controls, drives integration of ISO 14971 risk management into the software development lifecycle (SDLC), and ensures alignment to IEC 62304 and applicable Software as a Medical Device (SaMD) expectations. Post-market signals are leveraged as structured inputs to design improvements. Ensures traceability and alignment across design inputs, verification, and validation to meet regulatory expectations under all applicable design and development regulations and standards.
Foundations of Success
-
Lead with Ownership: Demonstrate accountability and integrity in all actions.
-
Act with Speed: Drive timely, effective solutions and keep stakeholders informed.
-
Foster Partnerships: Build strong, collaborative relationships across functions.
-
Delight Customers: Champion innovative, customer-centric improvements.
-
Celebrate Wins: Inspire and recognize impactful results and team achievements.
Essential Duties and Responsibilities
The incumbent may be required to perform additional duties related to the functions listed below:
Software Design Quality Ownership
- Serves as Design Quality representative on software NPD core teams.
- Owns design quality strategy for new and modified software-enabled products.
- Ensures design inputs are complete, testable, and aligned to intended use.
- Ensures design outputs are appropriately translated into production specifications.
- Approves software design quality deliverables, including design inputs, risk analyses, V&V strategy, and design reviews.
Risk Management Integration
- Owns software-related risk management activities per ISO 14971.
- Ensures traceable linkage between hazards, design requirements, and verification evidence.
- Maintains risk files with production and post-production feedback per ISO 14971 Section 10.
Verification and Validation Strategy
- Approves risk-based V&V approaches for software systems.
- Ensures validation reflects real-world use conditions and user needs.
- Confirms V&V coverage is traceable to requirements and identified hazards.
- Determines adequacy of verification and validation evidence relative to intended use and risk.
Software and System Behavior
- Leads analysis of software-related failure modes, with focus on real-world use conditions and system interactions.
- Drives design improvements to strengthen system robustness, error handling, and user-visible behavior.
- Ensures software and system behavior are sufficiently defined and diagnosable to support effective investigation of field issues.
Post-Market Signal Integration
- Reviews software-related complaint trends and field signals as inputs to design.
- Translates signals into design improvements, risk file updates, or verification gap closure.
- Engages in complaint investigations where software or system behavior indicates potential design or risk control gaps.
Cross-Functional Leadership
- Drives alignment across R&D, Systems, Regulatory, and Service.
- Influences product decisions to improve quality, reliability, and compliance.
- Mentors junior engineers on software design quality practices.
- Serves as the quality authority in design reviews, providing independent oversight per ISO 13485 design control expectations.
Requirements / Qualifications
Qualifications will be assessed holistically, and equivalent education, experience, and demonstrated skills may fulfill these requirements.
- Bachelor’s degree in computer science, software engineering, or related technical discipline; advanced degree preferred.
- 8+ years of experience in quality, software, or systems engineering within the medical device or comparable regulated industry.
- Demonstrated experience in software NPD / design assurance activities in regulated medical devices, including design controls and risk management.
- Deep working knowledge of ISO 13485, FDA QMSR (21 CFR 820), ISO 14971, and IEC 62304.
- Proven experience translating field issues into design changes and closed-loop risk updates.
- Experience with SaMD and QI/ML-enabled medical devices preferred; familiarity with FDA guidance on AI/ML and the EU Act is a plus.
- Strong technical leadership, cross-functional influence, and written communication skills.
- Experience with software system architecture, interfaces, and failure modes in complex electromechanical systems.
- Preferred certifications: ASQ CQE or CSQE, or a comparable quality or reliability certification.
Why join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
LI-AV1
Hologic is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
Position Summary
The Senior Software Design Quality Engineer serves as a senior Design Quality authority for software-enabled in-vitro diagnostics (IVD) medical devices across the development lifecycle. This includes software-enabled diagnostic systems incorporating image analysis and AI/ML-based algorithms to support detection and classification of cellular abnormalities. Embedded on New Product Development (NPD) core teams, this role owns software design controls, drives integration of ISO 14971 risk management into the software development lifecycle (SDLC), and ensures alignment to IEC 62304 and applicable Software as a Medical Device (SaMD) expectations. Post-market signals are leveraged as structured inputs to design improvements. Ensures traceability and alignment across design inputs, verification, and validation to meet regulatory expectations under all applicable design and development regulations and standards.
Foundations of Success
-
Lead with Ownership: Demonstrate accountability and integrity in all actions.
-
Act with Speed: Drive timely, effective solutions and keep stakeholders informed.
-
Foster Partnerships: Build strong, collaborative relationships across functions.
-
Delight Customers: Champion innovative, customer-centric improvements.
-
Celebrate Wins: Inspire and recognize impactful results and team achievements.
Essential Duties and Responsibilities
The incumbent may be required to perform additional duties related to the functions listed below:
Software Design Quality Ownership
- Serves as Design Quality representative on software NPD core teams.
- Owns design quality strategy for new and modified software-enabled products.
- Ensures design inputs are complete, testable, and aligned to intended use.
- Ensures design outputs are appropriately translated into production specifications.
- Approves software design quality deliverables, including design inputs, risk analyses, V&V strategy, and design reviews.
Risk Management Integration
- Owns software-related risk management activities per ISO 14971.
- Ensures traceable linkage between hazards, design requirements, and verification evidence.
- Maintains risk files with production and post-production feedback per ISO 14971 Section 10.
Verification and Validation Strategy
- Approves risk-based V&V approaches for software systems.
- Ensures validation reflects real-world use conditions and user needs.
- Confirms V&V coverage is traceable to requirements and identified hazards.
- Determines adequacy of verification and validation evidence relative to intended use and risk.
Software and System Behavior
- Leads analysis of software-related failure modes, with focus on real-world use conditions and system interactions.
- Drives design improvements to strengthen system robustness, error handling, and user-visible behavior.
- Ensures software and system behavior are sufficiently defined and diagnosable to support effective investigation of field issues.
Post-Market Signal Integration
- Reviews software-related complaint trends and field signals as inputs to design.
- Translates signals into design improvements, risk file updates, or verification gap closure.
- Engages in complaint investigations where software or system behavior indicates potential design or risk control gaps.
Cross-Functional Leadership
- Drives alignment across R&D, Systems, Regulatory, and Service.
- Influences product decisions to improve quality, reliability, and compliance.
- Mentors junior engineers on software design quality practices.
- Serves as the quality authority in design reviews, providing independent oversight per ISO 13485 design control expectations.
Requirements / Qualifications
Qualifications will be assessed holistically, and equivalent education, experience, and demonstrated skills may fulfill these requirements.
- Bachelor’s degree in computer science, software engineering, or related technical discipline; advanced degree preferred.
- 8+ years of experience in quality, software, or systems engineering within the medical device or comparable regulated industry.
- Demonstrated experience in software NPD / design assurance activities in regulated medical devices, including design controls and risk management.
- Deep working knowledge of ISO 13485, FDA QMSR (21 CFR 820), ISO 14971, and IEC 62304.
- Proven experience translating field issues into design changes and closed-loop risk updates.
- Experience with SaMD and QI/ML-enabled medical devices preferred; familiarity with FDA guidance on AI/ML and the EU Act is a plus.
- Strong technical leadership, cross-functional influence, and written communication skills.
- Experience with software system architecture, interfaces, and failure modes in complex electromechanical systems.
- Preferred certifications: ASQ CQE or CSQE, or a comparable quality or reliability certification.
Why join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
LI-AV1
Hologic is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
See all 49+ Green Card Software Design Engineer Jobs
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Get Access To All JobsTips for Finding Green Card Sponsorship as a Software Design Engineer
Align your degree to the job description
PERM labor certification requires your degree field to match the role's minimum requirements. A computer science or software engineering degree maps cleanly, but an unrelated bachelor's paired with years of experience can complicate DOL audit responses and slow certification.
Target employers with active PERM filings
Use Migrate Mate to filter Software Design Engineer roles by employers who have filed PERM applications, so you're targeting companies already familiar with the DOL certification process rather than educating a reluctant hiring team.
Understand EB-2 versus EB-3 before your offer
If your role requires an advanced degree or you have a master's, push for EB-2 classification before signing an offer. EB-3 is accessible but carries longer priority date backlogs for certain countries, which affects when you can file I-485.
Verify your employer's E-Verify enrollment early
PERM-sponsored employers aren't required to use E-Verify, but many large tech employers are enrolled. Confirming enrollment before your offer stage prevents surprises during I-9 verification and signals the employer's readiness to handle federal compliance.
Request the PERM timeline in writing before accepting
PERM labor certification can take six to twelve months at DOL before the I-140 petition even begins. Ask your employer to outline their intended filing schedule, including whether they plan to use PERM audit defense counsel, before you resign your current position.
Check prevailing wage before negotiating your offer
Your employer must pay at least the DOL prevailing wage for your role and location throughout the PERM and green card process. Run your job title and ZIP code through the OFLC Wage Search before negotiations so you know the floor your offer must clear.
Green Card Software Design Engineer: Frequently Asked Questions
Does a Software Design Engineer role qualify for EB-2 or EB-3 sponsorship?
Most Software Design Engineer positions qualify for EB-3 at minimum, since they require a bachelor's degree in computer science, software engineering, or a related field. EB-2 is available when the role genuinely requires a master's degree or when you hold one and can demonstrate it's customarily required. Your employer's attorney documents the minimum requirements during PERM, so the job description language matters significantly.
How does PERM green card sponsorship differ from H-1B for this role?
H-1B visa is a temporary status capped at 65,000 slots annually and subject to lottery selection, while PERM-based green card sponsorship has no annual cap at the petition level. The tradeoff is time: PERM and I-140 processing can run 18 months or longer before you even reach the priority date queue. Green card sponsorship leads to permanent residency, not a renewable temporary status.
Can I switch employers during the PERM or green card process?
Changing employers restarts the PERM process entirely, since the certification is tied to a specific employer and job offer. Once your I-140 is approved and you've been in adjustment of status for 180 days, AC21 portability lets you move to a similar role without losing your priority date. Software Design Engineer roles typically qualify as sufficiently similar under USCIS portability guidance.
Where can I find Software Design Engineer jobs with green card sponsorship?
Migrate Mate lets you search Software Design Engineer roles filtered by employers who have filed employment-based green card petitions, which saves significant time compared to manually researching PERM disclosure data. Filtering by sponsorship history surfaces hiring teams already experienced with the PERM and I-140 process, reducing the risk of a sponsorship offer falling apart mid-process.
How long does the green card process take for a Software Design Engineer born in India or China?
Applicants born in India or China face priority date backlogs that can extend the total green card timeline by many years beyond the initial PERM and I-140 processing period. The EB-2 and EB-3 preference categories for these countries are heavily oversubscribed. USCIS publishes a monthly Visa Bulletin with current priority dates, which is the only reliable way to track where your place in the queue stands.