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Lead Design Engineer - Medical Consumables

Research & Development
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At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health

What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.

None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.

While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.

Summary of Duties and Responsibilities

You will be part of an enthusiastic, dynamic, results-oriented team of development engineers, and interface directly with scientists, product managers, regulatory specialists, quality engineers and manufacturing operations working to define and develop Hologic’s best-in-class biopsy products. The ideal candidate is one who understands biopsy medical devices and how they are used in the clinical environment. 

  • Primary role is to support medical consumable products.  Being directly involved with and/or overseeing the design and development of complex electro mechanical devices and systems for mammography, breast biopsy, and specimen radiography products.
  • Participates in the manufacture or building of prototype product or system.
  • Position will use SolidWorks for modeling parts, assemblies, and drawings. Will use SolidWorks PDM for CAD data management. Will use an electronic product data management systems (AGILE preferred) for engineering change management.
  • Confers with project managers, engineers and research personnel to clarify and resolve problems and develop designs.
  • Participates in scheduled department meetings to report progress of overall project or portion of project and required to prepare and give design presentations.
  • Analyzes test data and reports to determine if design meets functional and performance specifications.
  • Create and manage product requirements and design specifications.
  • Directs activities to ensure that manufacturing, construction and operational testing conform to functional specifications, user needs, and customer requirements.
  • Uses computer assisted engineering and design software to perform engineering tasks.
  • Lead technical development team, as required.
  • Produce DHF documentation in support of design projects.
  • Complete design documentation and Engineering Change Orders, as required by Hologic standard operating procedures.
  • Hold device design requirements reviews with internal and external stakeholders (suppliers) as required
  • Develop and maintain component or high level assembly purchasing specifications, including critical to quality parameters, ensuring requirements are well defined, and suppliers can fulfill and test to the specifications
  • Propose alternative design concepts in collaboration with other technical staff, to meet product definitions and evaluate based on risk, product cost, performance, safety, and reliability considerations
  • Ensure that design implementation and test methods are developed and executed in a manner that supports quality standards, whether designed in-house, or utilizing suppliers
  • Performs a wide variety of complex technical tasks to assist design engineers with developmental operations. 
  • Create and/or participate in developing Design Requirement Documents, Design Verifications, Work Procedures and Test Procedures. 
  • Facilitate Design Transfer to Manufacturing. 
  • Work in FDA/ISO/MDD regulated environment.
  • Recognizes and reports problems affecting successful completion of project, is instrumental in suggesting or effecting solution.
  • Significant technical contributor to generation of specifications and schedules.
  • Manages outside resources, as required.

  • Exceptional knowledge of DFM. Fabrication methods commonly used with Hologic consumables are Injection Molding, machined, and sheet metal parts. Injection molded part design is a plus, as well as metal casting design.
  • Strong medical consumables experience: Age testing, Sterilization, Reliability testing. Having worked closely with contract manufacturers and component suppliers.  Experience with designs for hi-speed automation a plus.
  • Familiarity with capital equipment development a plus.
  • 5-7 years building what they designed. Good hands on skill, the candidate will need to build much of what they design at Hologic.
  • Minimum 6 years of SolidWorks 3D modeling and 2D drafting. Surfacing is a plus.
  • Experience with DFMEAs, PFMEAs, Risk reviews, and Design Verification.
  • Proficiency with load and stress analysis, GD&T, tolerance analysis, and statistical analysis.
  • Able to
    • Able to handling of constructive criticism positively and professionally.  Hologic often uses peer reviews to reduce risk and develop the most optimized designs, also good learning opportunity.
    • work well with diverse groups of people, interact effectively with cross-functional teams and partner with functional managers and other departments
    • manage multiple tasks and priorities simultaneously and adapt to changes in program priorities
    • transform physical and mathematical concepts into sound engineering designs
    • define clear and effective product design requirements and specifications
    • communicate effectively, both in writing and verbally
  • Familiar with international standards for biocompatibility of materials used in medical devices
  • Familiar with FDA QSR and ISO 13485 design control requirements.
  • Proficiency with Microsoft Office.
  • Bachelor’s degree in Biomedical or Mechanical Engineering
  • Master’s degree in Engineering, a plus
  • A minimum 10 years of experience designing and developing medical devices.

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.


Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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