Manufacturing Engineer 2
Hologic•San Diego, CA
•$79,500 - $124,000
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.
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
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
- Must follow all applicable FDA regulations and ISO requirements.
Benefits
- bonus eligible
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
