Hologic, Inc. · 4 days ago
Quality Design Engineer II
Newark, DE
Full-time
Onsite
Entry, Mid Level
$77K/yr - $120K/yr
2+ years expHologic, Inc. is focused on healthcare innovation and is seeking a Quality Design Engineer II to enhance the quality and safety of medical devices. The role involves leading design changes, conducting root cause investigations, and ensuring compliance with regulatory standards while collaborating across departments to improve product performance and customer satisfaction.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Lead design changes, product enhancements, and quality projects while ensuring compliance with regulatory standards
Collaborate across departments to analyze post-market data and conduct root cause investigations
Develop solutions that enhance product performance and customer satisfaction
Ensure compliance with design verification and validation requirements
Develop test methods, protocols, and reports for design verification, validation, and process validation activities
Qualification
Required
Expertise in FDA Quality Systems Regulation (QSR), Design Control requirements, ISO 13485, ISO 14971 (Risk Management), and Medical Devices Directive
Strong understanding of manufacturing processes, including machining, injection molding, common joining methods, and rapid prototyping
Knowledge of tolerance stack-ups, Design for Manufacturability (DFM), and Geometric Dimensioning & Tolerancing (GD&T)
Familiarity with Good Laboratory Practices and risk management tools throughout the product lifecycle
Proven ability to lead design changes, product enhancements, and quality projects, ensuring compliance with design verification and validation requirements
Strong knowledge of root cause failure analysis, statistical methods, and design of experiments (DOE)
Competency in statistical analysis tools, such as MiniTab, for data-driven decision-making
Proficiency with CAD tools (e.g., SolidWorks) to design fixtures and prototypes supporting validation activities
Technical writing skills for authoring protocols, reports, requirements, and risk documentation
Ability to develop test methods, protocols, and reports for design verification, validation, and process validation activities
Collaborative team player with strong communication skills to work effectively across R&D, Quality, and Regulatory teams
Action-oriented and detail-focused, ensuring timely and accurate execution of tasks and deliverables
Proactive problem solver with the ability to assess product and process risks and propose innovative solutions
Customer-focused, committed to resolving quality issues and enhancing customer experiences
Continuous improvement mindset, driving process optimization and identifying opportunities for technical learning
Adaptable and resilient, thriving in a fast-paced, regulated environment while maintaining compliance with global standards
Bachelor's degree in engineering, scientific discipline, or a related field (e.g., BSME, BSEE)
At least 2 years of experience in a medical device process and/or product development environment
Hands-on experience with design verification/validation, risk management, and complaint investigations
Proven track record in developing solutions to design and process challenges using engineering principles and empirical methods
Benefits
Comprehensive training
Continued development and training
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