Design Quality Engineer 2

Hologic•San Diego, CA

15d

About The Position

Here at Hologic, our purpose is to enable healthier lives everywhere, every day—and we’re driven by our passion to be the global champion for women’s health by bringing The Science of Sure to life. We’re looking for a Design Quality Engineer 2 to be a key member of our Quality Engineering team, supporting design control and quality activities across the product lifecycle. In this role, you’ll 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. You’ll 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. If you’re a strong communicator, a collaborative problem-solver, and passionate about high-quality product design in a regulated environment, this role is for you.

Requirements

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.