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Senior Capital Product Engineer, Surgical

Marlborough, MA, United States

We are seeking an accomplished **Senior Capital Product Engineer** to ensure our capital medical device products consistently meet the needs of customers and regulatory bodies throughout their lifecycle. In this pivotal role, you will own the maintenance of Design History Files (DHF), collaborate cross-functionally to drive product improvements, and lead documentation and compliance efforts across our portfolio.

Key Responsibilities:

+ Maintain and update Design History Files (DHF) for each product, including Design Inputs, Outputs, Verification, Validation, and Compliance documentation.

+ Partner with R&D engineers to gain in-depth technical knowledge of device electrical, hardware, and systems architecture.

+ Author and approve all DHF changes, leveraging expertise in Design Controls and collaborating with Regulatory, Post Market Quality, Manufacturing, and Marketing stakeholders.

+ Lead troubleshooting and root cause analysis for returned units, pulling in R&D experts as needed and developing robust solutions.

+ Assess the impact of product changes on DHF, authoring technical rationales and developing testing strategies as needed.

+ Develop proficiency in Hologic’s QMS and Risk Management procedures, supporting integration of acquired products and remediation of legacy documentation.

+ Build and maintain risk management files (FMEA, Hazard Analysis) and requirements traceability documentation.

+ Support technical product knowledge for domestic and international tenders and regulatory inquiries.

+ Ensure compliance of medical device portfolio with IEC 60601 standards, including impact assessments of design changes.

+ Proactively address End-of-Life (EOL) components, leading engineering changes to ensure uninterrupted production.

+ Communicate and manage tradeoffs between conflicting priorities, driving project plans and timely progression.

+ Build collaborative relationships across HW, SW, Systems R&D, Manufacturing, Quality, and external partners.

+ Represent the voice of the end user throughout the development cycle, driving continuous product improvement.

+ Contribute to intellectual property development through invention and patent applications.

+ Supervise and provide direction to engineers and technicians within project scope.

Qualifications:

+ Bachelor’s or Master’s in Biomedical, Systems, Electrical Engineering, or related field

+ 5+ years (Bachelor’s) or 3+ years (Master’s) experience in medical device industry

+ Proven track record with complex capital medical devices and technical documentation

+ Skilled in risk management, design controls, product lifecycle, and IEC 60601 compliance

+ Proficient in developing specifications, test methods, and troubleshooting complex systems

+ Familiar with embedded systems; effective collaborating across hardware and software teams

+ Strong technical writing and communication skills for diverse audiences

+ Cross-functional leadership experience in a matrix environment; excellent interpersonal skills

Travel:

Ability to travel as necessary, up to 10%.

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 $97,600 - $152,700 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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