Hologic, Inc. · 1 week ago
Design Quality Engineer 2
San Diego, CA
Full-time
Onsite
Entry, Mid Level
$80K/yr - $125K/yr
2+ years expHologic, Inc. is dedicated to improving women's health through innovative medical solutions. They are seeking a Design Quality Engineer 2 to support design control and quality activities across the product lifecycle, ensuring compliance with FDA and international regulations while collaborating with product development teams.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Partner closely with product development teams to ensure new and updated IVD and medical device products are designed, verified, validated, and transferred in full compliance with FDA QSR, ISO 13485, IVDR/MDR, and other global regulations
Help shape requirements, assess design changes from a systems perspective, support risk management, and contribute to CAPA and nonconformance activities—directly influencing product safety, reliability, and performance
Work as a core Quality representative on New Product Development teams, ensuring proper application of design controls from feasibility through commercialization and post-launch changes
Review and approve design control and risk management documentation (user requirements, product specs, verification/validation protocols and reports, risk management files, FMEAs)
Design, develop, and implement Design Control QMS SOPs, forms, protocols, and report templates
Assess design changes from a systems perspective, identify risks, define mitigations, and evaluate effectiveness of risk controls
Support R&D with platform/systems reliability testing and characterization for hardware and software
Provide clear guidance on Quality System and Design Control requirements to cross-functional teams
Lead or support nonconformance and CAPA activities related to design (NCE and CAPA processes)
Support regulatory inspections and audits related to design control documentation
Qualification
Required
Strong working knowledge of FDA 21 CFR 820 Quality System Regulation, ISO 13485, CE Mark requirements, IVDR (EU 2017/746) and MDR (EU 2017/745)
Understanding of ISO 14971 risk management and its application to design, development, and change management
Extensive understanding of design controls, including design planning, inputs, outputs, verification, validation, design transfer, and design changes
Knowledge of verification and validation methodologies for both hardware and software, including system-level and reliability testing
Good grasp of scientific principles and concepts relevant to IVDs and medical device development
Familiarity with quality system tools such as CAPA, complaint management, and document control systems
Ability to work as a core Quality representative on New Product Development teams, ensuring proper application of design controls from feasibility through commercialization and post-launch changes
Skilled in reviewing and approving design control and risk management documentation (user requirements, product specs, verification/validation protocols and reports, risk management files, FMEAs)
Experience designing, developing, and implementing Design Control QMS SOPs, forms, protocols, and report templates
Strong capability to assess design changes from a systems perspective, identify risks, define mitigations, and evaluate effectiveness of risk controls
Experience supporting R&D with platform/systems reliability testing and characterization for hardware and software
Proficient with electronic PLM systems, ERP tools, and electronic quality tools (eCAPA, complaint management systems)
Strong communication skills—able to provide clear guidance on Quality System and Design Control requirements to cross-functional teams
Ability to lead or support nonconformance and CAPA activities related to design (NCE and CAPA processes)
Comfortable supporting regulatory inspections and audits related to design control documentation
Effective communicator, strong team player, and creative 'out-of-the-box' thinker
Strong influencing and negotiation skills—able to drive quality requirements while partnering constructively with R&D and other stakeholders
Detail-oriented and structured, with a focus on compliance, completeness, and clarity in documentation
Proactive and solutions-focused, identifying potential design issues early and helping teams address them
Committed to continuous improvement, both in product design and in design control processes and tools
Bachelor's degree in engineering or a life science discipline, or equivalent combination of education and experience
2–5 years of design control and/or quality product design experience in a regulated environment, ideally in the IVD or medical device space
Hands-on experience with design, development, verification, and validation activities
Experience working within a certified Quality Management System for medical devices/IVDs
Benefits
PTO
Employee Stock Purchase Plans
Exciting Employee Wellness plans
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