Product Engineer Visa Sponsorship Jobs in Massachusetts
Massachusetts is a strong market for product engineers, with major employers across Greater Boston, Cambridge, and the Route 128 corridor spanning biotech, software, and hardware sectors. Companies like Amazon, HubSpot, Wayfair, and Raytheon Technologies have active engineering hiring programs and established visa sponsorship processes for qualified international candidates.
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Get Access To All JobsJoin Hologic, a global leader in women's health, dedicated to developing innovative medical technologies that help detect, diagnose, and treat disease with greater accuracy and confidence. Headquartered in Marlborough, MA, Hologic's solutions impact millions of women worldwide across breast health, gynecologic health, and diagnostics. As part of our team, you'll contribute to products that improve patient outcomes and advance the standard of care, helping fulfill our mission of enabling healthier lives everywhere.
Position Summary
Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Sr. Product Quality Engineer to provide engineering support for on-market medical devices. In this role, you’ll lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross-functional teams, you’ll drive process improvements, assess risks, and deliver impactful solutions that enhance patient safety and customer satisfaction. If you’re a proactive problem-solver with a strong background in quality engineering, we encourage you to apply and make a difference in healthcare innovation.
The Sr. Product Quality Engineer provides advanced quality engineering support across the post market life cycle. This role leads cross-functional quality initiatives, supports field engineering and complaint handling processes and teams, and ensures processes comply with applicable regulations, standards, and Hologic’s Quality Management System. Operating with minimal supervision, the position drives investigations, root cause analysis, risk management, and continuous improvement while mentoring junior engineers.
Knowledge:
- Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP.
- Familiarity with root cause analysis tools, risk management principles, and compliance frameworks.
- Preferred knowledge of test method validation, statistical methods, design of experiments (DOE), and industry standards related to reliability, sterilization, packaging, and biocompatibility.
Skills:
- Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues.
- Strong data analysis and trending skills to identify risks, assess failure modes, and recommend mitigations.
- Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership.
- Ability to assess product changes for design and risk management impact, ensuring compliance and quality standards are maintained.
- Proficiency in developing or improving testing methods for complaint investigations and technical activities.
- Experience collaborating with cross-functional teams, including Operations, R&D, and Engineering, to drive product and process improvements.
- Preferred: Familiarity with verification and validation requirements and the development of testable and measurable specifications.
Behaviors:
- Detail-oriented and compliance-focused, ensuring adherence to regulatory standards and quality system requirements.
- Proactive and results-driven, with a strong sense of ownership for deliverables and outcomes.
- Collaborative and team-oriented, building productive relationships across functions to drive quality improvements.
- Customer-focused, with a commitment to addressing field quality issues and ensuring timely resolution.
- Continuous improvement mindset, driving process optimization and identifying opportunities to enhance product quality.
Experience:
- Bachelor’s degree in engineering (Mechanical, Biomedical, Biomechanical, Electrical, or related discipline) required.
- 5+ years of experience in quality engineering, product development, or R&D, preferably in an FDA-regulated industry.
- Hands-on experience in complaint investigations, root cause analysis, and CAPA activities.
- Familiarity with internal and external audits, including Notified Body and FDA inspections.
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 $98,000-$135,100 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.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Join Hologic, a global leader in women's health, dedicated to developing innovative medical technologies that help detect, diagnose, and treat disease with greater accuracy and confidence. Headquartered in Marlborough, MA, Hologic's solutions impact millions of women worldwide across breast health, gynecologic health, and diagnostics. As part of our team, you'll contribute to products that improve patient outcomes and advance the standard of care, helping fulfill our mission of enabling healthier lives everywhere.
Position Summary
Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Sr. Product Quality Engineer to provide engineering support for on-market medical devices. In this role, you’ll lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross-functional teams, you’ll drive process improvements, assess risks, and deliver impactful solutions that enhance patient safety and customer satisfaction. If you’re a proactive problem-solver with a strong background in quality engineering, we encourage you to apply and make a difference in healthcare innovation.
The Sr. Product Quality Engineer provides advanced quality engineering support across the post market life cycle. This role leads cross-functional quality initiatives, supports field engineering and complaint handling processes and teams, and ensures processes comply with applicable regulations, standards, and Hologic’s Quality Management System. Operating with minimal supervision, the position drives investigations, root cause analysis, risk management, and continuous improvement while mentoring junior engineers.
Knowledge:
- Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP.
- Familiarity with root cause analysis tools, risk management principles, and compliance frameworks.
- Preferred knowledge of test method validation, statistical methods, design of experiments (DOE), and industry standards related to reliability, sterilization, packaging, and biocompatibility.
Skills:
- Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues.
- Strong data analysis and trending skills to identify risks, assess failure modes, and recommend mitigations.
- Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership.
- Ability to assess product changes for design and risk management impact, ensuring compliance and quality standards are maintained.
- Proficiency in developing or improving testing methods for complaint investigations and technical activities.
- Experience collaborating with cross-functional teams, including Operations, R&D, and Engineering, to drive product and process improvements.
- Preferred: Familiarity with verification and validation requirements and the development of testable and measurable specifications.
Behaviors:
- Detail-oriented and compliance-focused, ensuring adherence to regulatory standards and quality system requirements.
- Proactive and results-driven, with a strong sense of ownership for deliverables and outcomes.
- Collaborative and team-oriented, building productive relationships across functions to drive quality improvements.
- Customer-focused, with a commitment to addressing field quality issues and ensuring timely resolution.
- Continuous improvement mindset, driving process optimization and identifying opportunities to enhance product quality.
Experience:
- Bachelor’s degree in engineering (Mechanical, Biomedical, Biomechanical, Electrical, or related discipline) required.
- 5+ years of experience in quality engineering, product development, or R&D, preferably in an FDA-regulated industry.
- Hands-on experience in complaint investigations, root cause analysis, and CAPA activities.
- Familiarity with internal and external audits, including Notified Body and FDA inspections.
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 $98,000-$135,100 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.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Product Engineer Job Roles in Massachusetts
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Search Product Engineer Jobs in MassachusettsProduct Engineer Jobs in Massachusetts: Frequently Asked Questions
Which companies sponsor visas for product engineers in Massachusetts?
Several large employers in Massachusetts have consistent track records of sponsoring visas for product engineers. These include Amazon (with significant operations in Boston), Wayfair, HubSpot, MathWorks, Raytheon Technologies, and biotech firms like Biogen and Moderna. Massachusetts-based startups in the Route 128 and Kendall Square corridors also sponsor, though less predictably than established enterprises.
Which visa types are most common for product engineers in Massachusetts?
The H-1B visa is the most common visa for product engineers in Massachusetts, as these roles typically qualify as specialty occupations requiring a degree in computer science, electrical engineering, or a related field. Some employers also use the L-1B for intracompany transfers. Candidates with a relevant master's degree from a U.S. university may benefit from the advanced degree exemption during H-1B selection.
How to find product engineer visa sponsorship jobs in Massachusetts?
Migrate Mate filters job listings specifically by visa sponsorship willingness, making it easier to identify Massachusetts employers actively hiring product engineers on H-1B or other work visas. Rather than sorting through general postings, you can search directly for product engineer roles in Massachusetts where sponsorship is confirmed, saving significant time during a job search that may be constrained by visa timelines.
Which cities in Massachusetts have the most product engineer sponsorship jobs?
Boston and Cambridge account for the majority of product engineer sponsorship opportunities in Massachusetts, driven by the concentration of tech companies, research institutions, and startups around Kendall Square and the Seaport District. Waltham and Burlington along the Route 128 corridor are also notable clusters, particularly for hardware and defense-adjacent product engineering roles at companies like Raytheon and MathWorks.
Are there state-specific factors product engineers should know about when seeking sponsorship in Massachusetts?
Massachusetts has a dense university pipeline, with MIT, Boston University, Northeastern, and Tufts producing large numbers of engineering graduates, which means employer familiarity with OPT and H-1B processes is generally high. The state's biotech and medtech sectors add demand for product engineers with cross-functional skills. Prevailing wage determinations for Massachusetts product engineer roles reflect the high cost of the Greater Boston market, so employer LCA filings typically reflect competitive compensation levels.
What is the prevailing wage for sponsored product engineer jobs in Massachusetts?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.