Hologic, Inc. · 1 day ago
Senior Systems Quality Engineer
San Diego, CA
Full-time
Onsite
Senior Level
$98K/yr - $154K/yr
5+ years expHologic is a company focused on making a meaningful impact on women's health through innovative medical devices. They are seeking a Senior Systems Quality Engineer to lead investigations into hardware-related field failures, drive continuous improvement, and ensure compliance with global regulatory standards.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Lead investigations into hardware-related field failures
Drive continuous improvement efforts
Ensure compliance with global regulatory standards
Apply technical expertise and analytical skills to evaluate product complaints
Mitigate risks and collaborate across functions to deliver innovative solutions
Translate customer complaints into engineering hypotheses and structured investigation plans
Evaluate failed hardware components and interpret schematics
Develop and oversee system-level test plans for hardware design changes and field corrective actions
Manage multiple post-market issues simultaneously and prioritize tasks based on risk and customer impact
Communicate complex hardware/system issues to non-technical stakeholders
Present investigation summaries, CAPA progress, and risk updates to leadership teams
Mentor junior engineers and demonstrate strong technical leadership
Qualification
Required
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
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
Naturally curious and persistent in investigating ambiguous hardware failures
Challenges assumptions and validates findings with evidence while embracing learning and continuous improvement
Builds strong partnerships across engineering, manufacturing, quality, service, and suppliers
Communicates respectfully and adapts to diverse audiences
Bachelor's degree in Electrical, Mechanical, Biomedical, Systems Engineering, or related discipline required; Master's degree preferred
5–8+ years of experience in medical device hardware/system quality or post-market engineering (Master's degree preferred)
Proven track record in leading complex hardware investigations and CAPA execution
Experience with field service troubleshooting, reliability engineering, HALT/HASS, or environmental testing
Hands-on experience with optical systems, imaging hardware, robotics, RF, or high-precision mechanical assemblies (product-line dependent)
Demonstrated change management experience and ability to guide organizations to desired states
Willingness to travel as required for technical investigations at customer sites
Preferred
Master's degree preferred
Experience with field service troubleshooting, reliability engineering, HALT/HASS, or environmental testing
Hands-on experience with optical systems, imaging hardware, robotics, RF, or high-precision mechanical assemblies (product-line dependent)
Benefits
Comprehensive training when you join
Continued development and training throughout your career
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
2026-01-08
Company data provided by crunchbase