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Capital Sustaining R&D Manager

Marlborough, MA, United States

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.

Key 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.

Qualifications & Experience:

+ Bachelor’s or Master’s degree in Electrical Engineering, Systems Engineering, or Biomedical Engineering.

+ 8+ years of experience in the medical device industry, preferably sustaining complex capital products.

+ Demonstrated experience managing direct reports and leading multidisciplinary projects.

Skills & Attributes:

+ 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.

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 $122,000 - $203,300 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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