System Quality Engineer ; Hardware Post-Market

Are you ready to make a meaningful impact on the safety, reliability, and performance of cutting-edge medical devices? At Hologic, we are seeking a System Quality Engineer 3
- Hardware Post-Market to lead investigations into hardware-related field failures, drive continuous improvement, and ensure compliance with global regulatory standards. In this pivotal role, you will apply your technical expertise, analytical skills, and leadership capabilities to evaluate product complaints, mitigate risks, and collaborate across functions to deliver innovative solutions that uphold our commitment to women’s health. If you thrive in a fast-paced, highly regulated environment and are passionate about solving complex hardware challenges, we want to hear from you!

• Deep understanding of hardware engineering fundamentals, including electronics, PCBAs, sensors, electromechanical systems, and mechanical design principles.
• Expertise in system engineering concepts, such as requirements, interfaces, integration points, and failure modes.
• Strong knowledge of post-market engineering practices, including reliability engineering, complaint trending, failure analysis, and returned product evaluations.
• Familiarity with manufacturing processes related to electronics, mechanical assemblies, optics, and integration.
• Advanced understanding of FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, and global post-market surveillance requirements.
• Complaint handling processes, risk management practices, CAPA, NC/NCR, and design change controls.
• Understanding of verification/validation approaches for hardware and system-level design changes.
• Familiarity with FMEA/DFMEA/PFMEA, fault-tree analysis, hazard analysis, and risk-benefit evaluations.
• Proficiency in risk management tools, including FMEA/DFMEA/PFMEA, fault-tree analysis, hazard analysis, and risk-benefit evaluations.

• Proven ability to lead root cause analysis (RCA) using structured tools like 5-Why, Fishbone, Fault Tree, and Design of Experiments (DOE).
• Skilled in evaluating failed hardware components, interpreting schematics, analyzing logs, and replicating field failures.
• Expertise in developing and overseeing system-level test plans for hardware design changes and field corrective actions.
• Proficient in statistical methods for trend analysis, reliability modeling (MTBF, Weibull analysis), and failure probability assessments.
• Experience with testing tools such as oscilloscopes, meters, and diagnostic equipment.

• Ability to translate customer complaints into engineering hypotheses and structured investigation plans.
• Capable of simplifying complex technical issues into clear problem statements and actionable conclusions.
• Strong quantitative analysis skills for trend identification, correlation analysis, and reliability metrics.

• Effective communicator capable of explaining complex hardware/system issues to non-technical stakeholders.
• Skilled at presenting investigation summaries, CAPA progress, and risk updates to leadership teams.
• Collaborative team player, adept at working with R&D, Service Engineering, Manufacturing, Supplier Quality, and Regulatory Affairs.

• Strong documentation and technical writing skills for investigations, protocols, and CAPA records.
• Ability to manage multiple post-market issues simultaneously and prioritize tasks based on risk and customer impact.
• Project management capabilities to coordinate cross-functional tasks and timelines.

• Committed to product safety, regulatory compliance, and ensuring exceptional patient outcomes.
• Takes ownership of investigations from initiation to closure with rigor and urgency.

• Holistic problem solver who understands interactions between electrical, mechanical, software, optical, and manufacturing elements.
• Focuses on addressing systemic root causes rather than symptoms.

• Leads cross-functional investigation teams with confidence and fairness.
• Mentors junior engineers and demonstrates strong technical leadership.