Hologic, Inc. · 23 hours ago
Senior Product Quality Engineer
Newark, DE, United States
Full-time
Onsite
Mid, Senior Level
$98K/yr - $153K/yr
5+ years expHologic, Inc. is dedicated to enabling healthier lives everywhere, every day, and they are seeking a Senior Product Quality Engineer to lead post-market product quality efforts. This role involves driving complaint investigations, performing health risk assessments, and leading cross-functional teams to implement design and process changes.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Lead post-market product quality efforts by driving complaint investigations, root cause analysis, and implementation of corrective and preventive actions
Own complex investigations and perform health risk assessments
Lead cross-functional teams to implement design and process changes
Provide data-driven insights that improve product performance in the field
Qualification
Required
Working knowledge of FDA Quality System Regulations (21 CFR 820), especially Design Control requirements
Familiarity with ISO 13485, EU Medical Device Regulation (MDR), ISO 14971 (Risk Management), GMP, and GDP
Strong understanding of root cause analysis tools and their application to complaints, nonconformances (NCs), and CAPAs
Ability to lead and own investigations into post‑market complaints, including structured root cause analysis and effective stakeholder coordination and communication
Strong data analysis skills to trend complaint data and failure modes, identify threshold risks, propose mitigations, and prepare clear summaries for leadership
Proven capability to lead cross‑functional teams in implementing improvements or corrections, including design and process changes (drawing updates, fixtures, tooling, testing, and change control documentation)
Skilled in developing or improving testing methods used during complaint investigation and root cause activities
Proficient in executing and documenting Health Risk Assessments for on‑market products, clearly defining problem, impact, and risk
Able to assess product changes for impact on design and risk management, and determine the supporting information required for implementation
Excellent communication and presentation skills to share product quality metrics, explain root causes, and recommend actions/resolutions to leadership
Comfortable training and supporting complaint intake teams by providing technical expertise for complex investigations
Operates with a high degree of autonomy and independence, requiring only minor oversight even on complex problems
Detail‑oriented and compliance‑focused, acting as an advocate for regulatory and quality system requirements in documentation and decision‑making
Proactive and results‑driven, urgently identifying and resolving field quality issues while upholding the Hologic brand image and values
Collaborative team player who builds strong relationships with Operations, Engineering, R&D, Sales, and Service
Analytical and systematic problem‑solver, committed to identifying true root causes and implementing sustainable corrective actions
Confident representing investigations and post‑market quality activities in internal and external audits (facility, supplier, Notified Body, FDA)
Bachelor's Degree in Engineering required (Mechanical, Electrical, Biomedical preferred)
5+ years of experience with a Bachelor's degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering
Or 1–3 years with a Master's degree, or 0–1 year with a PhD in a related discipline
Experience in an FDA‑regulated industry (medical devices strongly preferred)
Preferred
Knowledge of test method validation, root cause failure analysis, statistical methods, and Design of Experiments (DOE)
Familiarity with Reliability, Electrical Safety, Sterilization, Packaging, and Biocompatibility standards and requirements
Working knowledge of verification and validation requirements for regulated products
Familiarity with requirements analysis and development of testable, measurable specifications
Understanding of risk‑based and statistical analysis concepts
Beneficial: Hands‑on experience in root cause analysis, product development, or R&D, particularly for complex devices/systems
Experience participating in internal and external audits and inspections is a plus
Benefits
Comprehensive training when you join
Continued development and training throughout your career
Bonus eligible
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