Hologic, Inc. · 4 days ago
Sr Manager, R&D, Sustaining Engineering
Newark, DE
Full-time
Onsite
Senior Level, Lead/Staff
$146K/yr - $244K/yr
8+ years expHologic, Inc. is seeking a dynamic and experienced Sr Manager, R&D, Sustaining Engineering to lead their multi-disciplinary engineering team in supporting the lifecycle management of capital equipment products. In this role, you will oversee sustaining engineering activities, drive operational excellence, and mentor a talented team to ensure the highest standards of quality and safety in healthcare.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Lead, mentor, and develop a high-performing, multi-disciplinary team responsible for sustaining engineering of on-market capital equipment
Oversee all sustaining activities, including ongoing compliance, design changes, maintenance, and compliant testing
Manage budgets, resource allocation, schedules, and adherence to quality standards
Implement strategic practices, optimize processes, and foster a culture of engineering excellence and continuous improvement
Guide root cause analyses and develop solutions for design issues, ensuring effective documentation, testing, and corrective actions
Build strong relationships with cross-functional teams, establish interdepartmental processes, and represent the sustaining engineering function within and outside Hologic
Ensure project plans are maintained, deliverables are met, and regular updates are provided on progress, risks, and resource needs
Standardize and enforce policies, procedures, and best practices in alignment with FDA, ISO, and internal requirements
Recruit, train, and develop team members; drive performance management and professional growth
Champion opportunities for innovation, process adoption, and ongoing product and system enhancements
Qualification
Required
Bachelor's degree in Engineering or related field required
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
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
Up to 10% domestic travel required
Preferred
Master's degree in Engineering or related field
Benefits
Comprehensive training when you join as well as continued development and training throughout your career
Competitive salary and annual bonus scheme
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
2026-01-08
Company data provided by crunchbase