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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. 

  • 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.

Qualifications
  • Demonstrated understanding of:
    • full product development cycle of medical devices from concept to product delivery
    • use of biopsy devices in the clinical environment
    • the design, fabrication and assembly of medical devices incorporating plastic and metal parts
  • Ability to:
    • 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
  • Strong background in 3D modeling, Solidworks preferred.
  • 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. 
Education       
  • Bachelor’s degree in Biomedical or Mechanical Engineering
  • Master’s degree in Engineering, a plus
Experience     
  • A minimum 10 years of experience designing and developing medical devices.
 
Additional Details

(Including Physical & Mental requirements)

  • Must be able to repetitively lift and carry product weighing approximately 30 lbs.
  • Up to 20% travel as necessary with potential for international travel

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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