Hologic Lead Engineer - Consumables in Marlborough, Massachusetts
Lead Engineer - Consumables
Post Date 6 days ago
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 designspecifications.
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 softwareto perform engineering tasks.
Lead technical development team, as required.
Produce DHF documentation in support of designprojects.
Complete design documentation and Engineering ChangeOrders, as required by Hologic standard operating procedures.
Hold device design requirements reviews with internaland external stakeholders (suppliers) as required
Develop and maintain component or high level assemblypurchasing specifications, including critical to quality parameters,ensuring requirements are well defined, and suppliers can fulfill and testto the specifications
Propose alternative design concepts in collaborationwith other technical staff, to meet product definitions and evaluate basedon risk, product cost, performance, safety, and reliability considerations
Ensure that design implementation and test methods aredeveloped and executed in a manner that supports quality standards,whether designed in-house, or utilizing suppliers
Performs a wide variety of complex technical tasks toassist design engineers with developmental operations.
Create and/or participate in developing DesignRequirement Documents, Design Verifications, Work Procedures and TestProcedures.
Facilitate Design Transfer to Manufacturing.
Work in FDA/ISO/MDD regulated environment.
Recognizes and reports problems affecting successfulcompletion of project, is instrumental in suggesting or effectingsolution.
Significant technical contributor to generation ofspecifications and schedules.
Manages outside resources, as required.
Demonstrated understanding of:
full product development cycle of medical devices fromconcept to product delivery
use of biopsy devices in the clinical environment
the design, fabrication and assembly of medicaldevices incorporating plastic and metal parts
work well with diverse groups of people, interacteffectively with cross-functional teams and partner with functionalmanagers and other departments
manage multiple tasks and priorities simultaneouslyand adapt to changes in program priorities
transform physical and mathematical concepts intosound engineering designs
define clear and effective product design requirementsand specifications
communicate effectively, both in writing and verbally
Strong background in 3D modeling, Solidworks preferred.
Familiar with international standards forbiocompatibility of materials used in medical devices
Familiar with FDA QSR and ISO 13485 design controlrequirements.
Proficiency with Microsoft Office.
Bachelor’s degree in Biomedical or Mechanical Engineering
Master’s degree in Engineering, a plus
- Aminimum 10 years of experience designing and developing medical devices.
(Including Physical & Mental requirements)
Must be able to repetitively lift and carryproduct weighing approximately 30 lbs.
Up to 20% travel as necessary with potential forinternational travel
Agency and Third PartyRecruiter 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 Employerinclusive of disability and veterans.