Capital Sustaining R&D Manager

Hologic•Marlborough, MA

11d•Onsite

About The Position

Join Hologic’s Surgical Division as our Capital Sustaining Manager and play a pivotal role in ensuring our industry-leading capital products continue to deliver exceptional value and reliability throughout their lifecycle. Be part of a collaborative, innovative environment where your expertise will will directly impact product continuity, quality, and team development. About the Role: As Capital Sustaining Manager, you will lead the strategic execution of all sustaining engineering activities for our Capital product portfolio. Acting as both a leader and a coach, you will oversee a team responsible for maintaining compliance, driving continuous improvement, and supporting cross-functional initiatives. You’ll be the key interface between Engineering, Regulatory, Quality, Manufacturing, and Marketing, ensuring business and customer needs are prioritized and met.

Requirements

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.

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.