Hologic is seeking a Manager, R&D, Systems Quality Assurance to lead a team of test engineers in delivering next-generation diagnostic systems and devices, ensuring high-quality products through effective testing and troubleshooting methods.
Requirements
- Comprehensive knowledge of operating systems (including real-time/embedded), test automation, electronics, and electro-mechanical equipment.
- In-depth experience testing commercial products at board, sub-system, and system levels.
- Proficient in technical equipment use (multimeters, oscilloscopes, etc.) and ability to train others.
- Thorough knowledge of mechanical drawings, schematics, and circuit diagrams.
- Deep understanding of medical device software development and regulatory standards.
- Experience with medical device manufacturing and regulatory requirements (FDA, FAA, SEC, etc.).
- Proven success leading high-performing test engineering teams in medical device product development.
Responsibilities
- Oversee design and implementation of test hardware and software, including creation and maintenance of test fixtures and equipment.
- Define requirements, specifications, and procedures for test equipment and processes that support quality standards.
- Review system-level documentation to ensure all safety, functional, and regulatory requirements are addressed in testing.
- Participate in design reviews, create test plans, and define user interface requirements for test equipment.
- Identify, diagnose, prioritize, and resolve technical issues; implement corrective actions to reduce defects and optimize processes.
- Champion continuous improvement by implementing best practices in software, hardware, and systems testing, and staying current on new technologies.
- Maintain expert-level understanding of products and their clinical use to guide the design, development, and testing of diagnostic systems.
Other
- Lead, mentor, and develop a high-performing team of test engineers, fostering engagement and continuous learning.
- Translate design objectives into actionable engineering programs, resource plans, schedules, and specifications.
- Provide technical and project leadership, ensuring clear objectives and accountability for results.
- Ensure on-time delivery of work products and develop project communication plans to track progress, schedule, budget, and risks.
- Build strong cross-functional relationships and collaborate to share resources and meet delivery needs.
