Manager, R&D, Systems Quality Assurance

Hologic-posted 3 months ago
$116,200 - $193,700/Yr
Full-time • Manager
Newark, DE
Computer and Electronic Product Manufacturing
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At Hologic, we are committed to advancing healthcare through innovative diagnostic systems and devices. As we continue to push the boundaries of technology and quality, we are seeking a passionate and experienced Manager, R D, Systems Quality Assurance to lead our talented team of test engineers in delivering next-generation solutions. This role is based out of Newark, DE and will require onsite presence. As the Manager, R D, Systems Quality Assurance, you will direct the activities of test engineers to design, develop, and implement cost-effective testing and troubleshooting methods for all phases of product development. You will foster a culture of operational excellence, continuous improvement, and high team engagement. In this critical leadership role, you will collaborate across departments to optimize resources and ensure on-time delivery of high-quality products.

  • Lead, mentor, and develop a high-performing team of test engineers, fostering engagement and continuous learning.
  • Maintain expert-level understanding of products and their clinical use to guide the design, development, and testing of diagnostic systems.
  • Translate design objectives into actionable engineering programs, resource plans, schedules, and specifications.
  • Provide technical and project leadership, ensuring clear objectives and accountability for results.
  • 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.
  • 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.
  • Responsible for recruiting, training, and developing team members, including performance management and professional development.
  • Champion continuous improvement by implementing best practices in software, hardware, and systems testing, and staying current on new technologies.
  • Bachelor's degree required; Master's degree preferred.
  • 8-10 years of relevant experience (or 5+ years with Master's, 3+ years with PhD).
  • Proven success leading high-performing test engineering teams in medical device product development.
  • Strong track record managing complex test projects, meeting budgets and deadlines.
  • Experience with medical device manufacturing and regulatory requirements (FDA, FAA, SEC, etc.).
  • Experience in matrixed organizations is beneficial.
  • Excellent written and verbal communication skills for technical and non-technical audiences.
  • Strong presentation and technical documentation skills.
  • 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.
  • Ability to drive departmental best practices and process improvements.
  • Deep understanding of medical device software development and regulatory standards.
  • Competitive salary and annual bonus scheme.
  • Comprehensive training upon joining and continued development throughout your career.
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