Manager, R&D, Systems Quality Assurance na 613.5310.0200 GYNESONICS - CORPORATE SALES MID-ATLANTIC REGION, US

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.

Key Responsibilities:

• 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.

Physical Demands:

• Sit, stand, walk, reach, stoop, kneel, crouch, or crawl.
• Lift/move/carry products up to 40 pounds.
• Exposure to moving mechanical parts, vibration, and moderate noise.

Qualifications:

• 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.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

The annualized base salary range for this role is $116,200 - $193,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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