Quality Design Engineer II
HologicNewark, Delaware, United States • Marlborough, Massachusetts, United States
Posted December 16, 2025
76800 - 120100 USD year
Full Time
About the Company
Hologic is an innovative medical technology company dedicated to enabling healthier lives through groundbreaking products and services. Specializing in Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions, the company excels in early detection and treatment of health conditions, driven by a commitment to women's health and a focus on clinical superiority. Hologic fosters a culture of expertise, dedication, and continuous improvement to meet unmet health needs globally.
Job Description
Hologic is seeking a Quality Design Engineer II to lead design changes, product enhancements, and quality projects while ensuring compliance with regulatory standards.
Requirements
- 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.
Benefits
- Comprehensive training and development opportunities
- Bonus eligibility
- Annualized base salary range: $76,800-$120,100