Manufacturing Engineer 2
About The Position
Hologic is seeking a Manufacturing Engineer II responsible for providing engineering support services including evaluation, purchase, installation, and qualification of new manufacturing equipment and sustainment of existing equipment and processes Provides engineering support for troubleshooting, modifying equipment and processes Supports equipment mechanics, technicians and manufacturing leads Create and/or modifies equipment maintenance procedures Writing and reviewing operating procedures, documents and reports Performs equipment, process and product performance testing Perform process transfers from Engineering to Manufacturing including processes and equipment training Support equipment Installation, Operation, and Performance Qualification Validations Reviews and approves calibration datasheets, work orders, PM’s and change controls Provides QS validation input and support for new equipment and process validations Writing and executing Installation, Operation, and Performance Qualification Validations; including writing final reports
Requirements
- Working knowledge of microprocessor controls, utility distribution systems and process engineering
- Basic knowledge of manufacturing automation systems and best design practice
- Knowledge of CGMPs, ISO 13485 and FDA 21 CFR 820
- Working knowledge of Windows based programs
- SolidWorks or Pro/E (3D modeling knowledge)
- MS Office and MS Project
- BA or BS degree (Mechanical Engineering preferred)
- Minimum 2-4 years of related industry experience
- Must follow all applicable FDA regulations and ISO requirements.
Nice To Haves
- LEAN & Six Sigma certification preferred but not required
Responsibilities
- Provides engineering support for troubleshooting, modifying equipment and processes
- Supports equipment mechanics, technicians and manufacturing leads
- Create and/or modifies equipment maintenance procedures
- Writing and reviewing operating procedures, documents and reports
- Performs equipment, process and product performance testing
- Perform process transfers from Engineering to Manufacturing including processes and equipment training
- Support equipment Installation, Operation, and Performance Qualification Validations
- Reviews and approves calibration datasheets, work orders, PM’s and change controls
- Provides QS validation input and support for new equipment and process validations
- Writing and executing Installation, Operation, and Performance Qualification Validations; including writing final reports
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
