H-1B Visa Software Design Engineer Jobs
Software Design Engineer roles sit squarely within H-1B visa specialty occupation criteria, requiring at least a bachelor's degree in computer science, software engineering, or a closely related field. Employers filing LCAs for this title regularly appear in DOL disclosure data, making it one of the more sponsorship-active job codes in tech.
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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 47+ H-1B Visa Software Design Engineer Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Software Design Engineer Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Software Design Engineer
Align your degree to the role
USCIS scrutinizes whether your specific degree field matches the Software Design Engineer title. A degree in computer science or software engineering is the cleanest fit. Degrees in adjacent fields like electrical engineering or information systems can work but may require a detailed employer explanation in the H-1B petition.
Search LCA filings before applying
DOL Labor Condition Application records show which employers have filed for Software Design Engineer roles by job title and location. Use Migrate Mate to filter for employers with active H-1B filing history in this occupation before you spend time on applications.
Request the prevailing wage tier early
Ask your recruiter which DOL prevailing wage level the employer intends to file at for this role. Levels I and II are common for new graduates but can draw RFEs if your responsibilities look senior. Confirm the offered salary meets or exceeds the certified LCA wage before signing.
Target E-Verify enrolled employers
USCIS requires your employer to be enrolled in E-Verify to sponsor H-1B workers. Confirm E-Verify enrollment during the offer stage, not after. Many smaller software firms and startups miss this requirement, which delays or blocks the petition filing entirely.
Document your design work for RFE defense
Build a portfolio of design artifacts: architecture diagrams, specification documents, and code reviews tied to distinct engineering decisions. If USCIS issues an RFE questioning specialty occupation, concrete evidence of design-level work is stronger than a job description alone.
File premium processing if your start date is firm
USCIS premium processing guarantees a decision within 15 business days. For Software Design Engineer roles with a specific project launch or team onboarding date, premium processing eliminates the uncertainty of standard adjudication timelines that can stretch several months.
H-1B Visa Software Design Engineer: Frequently Asked Questions
Does a Software Design Engineer role qualify as a specialty occupation for H-1B purposes?
Yes, Software Design Engineer consistently qualifies as a specialty occupation under USCIS criteria because the role normally requires at least a bachelor's degree in computer science, software engineering, or a directly related field. The O*NET profile for this occupation classifies it as requiring a four-year degree minimum, which supports the specialty occupation standard. Employers document this in the LCA and I-129 petition.
How do I find Software Design Engineer employers who actively sponsor H-1B visas?
The most direct method is reviewing DOL Labor Condition Application disclosure data, which lists every employer that has filed an LCA for a specific job title. Migrate Mate indexes this data so you can browse Software Design Engineer roles filtered by employers with verified H-1B filing history, avoiding the guesswork of cold-applying to companies without a sponsorship track record.
Can I transfer my H-1B to a new Software Design Engineer role at a different company?
Yes. Under AC21 portability, you can transfer your H-1B to a new employer in the same or a similar occupational classification once your I-140 has been approved and your H-1B has been approved for at least 180 days. The new employer files an H-1B transfer petition, and you can begin working for them as soon as USCIS receives that filing, without waiting for approval.
What happens to my H-1B status if my Software Design Engineer position is eliminated?
You have a 60-day grace period after your employment ends to find a new sponsoring employer, transfer your H-1B, or depart the U.S. Your current employer is required to pay for your return transportation to your home country if they terminate the relationship before your authorized stay ends. Filing an H-1B transfer petition within that 60-day window maintains your lawful status during adjudication.
Does the job title on my H-1B petition need to exactly match my business card?
The LCA job title and SOC code must accurately reflect the actual duties you perform, not necessarily mirror your internal title word for word. What matters is that your day-to-day responsibilities match the specialty occupation description in the petition. A significant mismatch between the filed title and your actual role can create problems during extensions, audits, or future green card filings, so alignment matters.