Hologic, Inc. · 20 hours ago
Senior Product Quality Engineer
Marlborough, MA
Full-time
Onsite
Mid, Senior Level
$98K/yr - $153K/yr
5+ years expHologic, Inc. is committed to ensuring the quality and safety of medical devices. They are seeking a Senior Product Quality Engineer to provide engineering support for on-market medical devices, leading investigations into post-market feedback and implementing corrective actions to uphold high standards of quality and safety.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Lead investigations into post-market feedback and complaints
Conduct root cause analyses
Implement corrective or preventive actions to ensure products meet quality and safety standards
Collaborate with cross-functional teams to drive product and process improvements
Perform independent health risk assessments and present findings to leadership
Assess and review written product and project documentation for compliance
Prioritize complaints and investigations based on risk, data analysis, and strategic impact
Implement design or process changes and manage change control documentation
Present product quality metrics, root cause analyses, and recommended actions to internal stakeholders and leadership
Qualification
Required
Strong understanding of FDA Quality System Regulations, particularly Design Control requirements
In-depth knowledge of ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management)
Familiarity with test method validation, root cause failure analysis, and statistical methods
Knowledge of system-level requirements for complex medical devices, including software, electromechanical, and hardware components
Awareness of reliability, electrical safety, sterilization, packaging, and biocompatibility standards
Proven ability to lead cross-functional teams in conducting investigations and implementing corrective and preventive actions (CAPAs)
Strong analytical skills to prioritize complaints and investigations based on risk, data analysis, and strategic impact
Excellent project management skills, including implementing design or process changes, performing testing, and managing change control documentation
Ability to perform independent health risk assessments and present findings to leadership
Effective communication skills to present product quality metrics, root cause analyses, and recommended actions to internal stakeholders and leadership
Strong ability to assess and review written product and project documentation for compliance
5+ years of experience in engineering, preferably in a regulated industry such as medical devices
Hands-on experience with root cause analysis, product development, or R&D
Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field)
Preferred
Experience with verification and validation requirements, design of experiments, and requirements analysis for regulated products
Benefits
Comprehensive training
Continued development and training
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
2026-01-17
Company data provided by crunchbase