Sr Manager, R&D, Sustaining Engineering

Hologic is seeking a dynamic and experienced Sr Manager, R&D, Sustaining Engineering to lead our multi-disciplinary engineering team in supporting the lifecycle management of capital equipment products. In this pivotal role, you will oversee all sustaining engineering activities—including ongoing compliance, design improvements, and product maintenance—ensuring our market-leading devices continue to meet the highest standards of quality, reliability, and safety. 

As the Sr. Manager, R&D, Sustaining Engineering you will champion organizational transformation, drive operational excellence, and mentor a talented team, while collaborating across departments to deliver innovative solutions that directly impact patient care. This is your opportunity to shape the future of our products and make a meaningful difference in healthcare. We are located in Newark, DE and we will require onsite presence. Appy today !

Key Responsibilities

• Team Leadership: Lead, mentor, and develop a high-performing, multi-disciplinary team responsible for sustaining engineering of on-market capital equipment.
• Product Lifecycle Management: Oversee all sustaining activities, including ongoing compliance, design changes, maintenance, and compliant testing.
• Budget & Resource Management: Manage budgets, resource allocation, schedules, and adherence to quality standards.
• Strategic Transformation: Implement strategic practices, optimize processes, and foster a culture of engineering excellence and continuous improvement.
• Technical Excellence: Guide root cause analyses and develop solutions for design issues, ensuring effective documentation, testing, and corrective actions.
• Stakeholder Collaboration: Build strong relationships with cross-functional teams, establish interdepartmental processes, and represent the sustaining engineering function within and outside Hologic.
• Project Management: Ensure project plans are maintained, deliverables are met, and regular updates are provided on progress, risks, and resource needs.
• Compliance & Quality: Standardize and enforce policies, procedures, and best practices in alignment with FDA, ISO, and internal requirements.
• Talent Management: Recruit, train, and develop team members; drive performance management and professional growth.
• Continuous Improvement: Champion opportunities for innovation, process adoption, and ongoing product and system enhancements.

What You’ll Bring

• Proven leadership and people management experience, with a track record of developing high-performing teams.
• Strong background in sustaining engineering of capital equipment, with expertise in medical device lifecycle management and regulatory requirements.
• Demonstrated success in budget management, organizational transformation, and driving change within matrixed organizations.
• Excellent project management, communication, and interpersonal skills.
• In-depth knowledge of FDA Quality System Regulation (Design Control), ISO 13485, ISO 14971, risk management, and medical device standards.
• Ability to solve complex technical challenges, assess compliance, and influence at all organizational levels.
• Experience with design for cost, reliability, serviceability, and manufacture.
• High business acumen, intellectual agility, and the ability to distill complex information into actionable recommendations.

Qualifications

• Education:
  • Bachelor’s degree in Engineering or related field required; Master’s preferred.
• Experience:
  • 8+ years in sustaining engineering, preferably with capital equipment products.
  • Minimum 5+ years of people management experience.
  • Experience with FDA regulations, ISO standards, and medical device lifecycle management.
  • Proven ability to lead, mentor, and develop teams in a fast-paced environment.
• Travel: Up to 10% domestic travel required.

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