R&D Manager, Product Engineering - Marlborough, MA jobs in United States
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Hologic, Inc. · 1 day ago

R&D Manager, Product Engineering - Marlborough, MA

Hologic, Inc. is a leading company in the medical device industry, and they are seeking a Capital Sustaining Manager to oversee sustaining engineering activities for their Capital product portfolio. The role involves leading a team to ensure compliance, drive continuous improvement, and support cross-functional initiatives, while acting as the key interface between various departments.

BiotechnologyHealth CareHealth DiagnosticsWomen's
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Communicate the strategic importance and direction of organizational goals, setting clear expectations and driving team engagement
Effectively allocate resources to Life Cycle Management (LCM), Quality, and Compliance projects, removing obstacles to ensure timely progress
Serve as the primary interface with senior stakeholders, balancing and communicating tradeoffs between competing priorities
Oversee product lifecycle activities, including electrical component End-of-Life (EOL) management and complex change implementation
Guide complex troubleshooting efforts for field returns and manufacturing issues, ensuring design changes are based on quality and risk imperatives
Direct maintenance and remediation of the Design History File (DHF), risk management files, and verification/testing strategies to ensure compliance with QMS standards
Own compliance strategy for the medical device portfolio, including standards like IEC 60601
Manage and develop direct reports, fostering technical and compliance growth within the team
Lead performance management processes, providing constructive feedback and professional development
Build and maintain strong collaborative relationships with key internal and external stakeholders
Advocate for and manage the team budget
Deliver exceptional verbal, written, and presentation communications for both technical and non-technical audiences
Collaborate cross-functionally to achieve project goals and drive an engaged, high-performing culture

Qualification

Electrical EngineeringMedical Device IndustryDesign ControlsProduct Lifecycle ManagementRisk ManagementTroubleshootingTechnical WritingInterpersonal SkillsCommunication SkillsTeam Leadership

Required

Bachelor's or Master's degree in Electrical Engineering
8+ years of experience in the medical device industry, preferably sustaining complex capital products
Demonstrated experience managing direct reports and leading multidisciplinary projects
In-depth knowledge of Design Controls and Product Lifecycle Management
Expertise in Risk Management and ability to guide product risk decisions
Outstanding communication and interpersonal skills; adept at building relationships and leading group discussions in a matrix organization
Strong troubleshooting capabilities for complex systems and technical challenges
Technical writing proficiency to guide protocols, reports, requirements, and risk documentation
Solid foundation in engineering disciplines (HW, SW, Systems) and ability to collaborate across teams

Benefits

Competitive salary and annual bonus scheme
Comprehensive training when you join as well as continued development and training throughout your career

Company

Hologic, Inc.

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We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.

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 Company
Total Funding
$2.87B
2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B

Leadership Team

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Stephen MacMillan
Chairman President & CEO
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Karen Harrington
Director Scientific Affairs
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Company data provided by crunchbase