Manufacturing Engineer I: Equipment & Process Optimization

Socket.dev; San Diego (CA); On-site; USD 64,000 - 100,000; Full time

Job summary

Hologic, Inc. in San Diego, CA is seeking a Manufacturing Engineer to provide engineering support for evaluation, purchase, installation, and qualification of new manufacturing equipment, and sustainment of existing equipment and processes.

You will troubleshoot and modify equipment and processes, support technicians and manufacturing leads, and help create maintenance procedures and operating documents. Qualified candidates will have CGMPs/ISO/FDA knowledge and SolidWorks/3D modeling skills.

Qualifications

• BA or BS degree in related field.
• 1–2 years of industry experience.
• Knowledge of CGMPs, ISO 13485 and FDA 21 CFR 820.

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.
• Support equipment Installation, Operation, and Performance Qualification Validations.
• Reviews and approves calibration datasheets, work orders, PMs and change controls.

Skills

Microprocessor controls

Process engineering

CGMPs ISO 13485 FDA 21 CFR 820

Windows based programs

SolidWorks

Pro/E

MS Office

MS Project

Education

BA/BS degree

1–2 years experience

Tools

SolidWorks or Pro/E

MS Office

MS Project

Job description

Hologic, Inc. in San Diego, CA is seeking a Manufacturing Engineer to provide engineering support for evaluation, purchase, installation, and qualification of new manufacturing equipment, and sustainment of existing equipment and processes.

You will troubleshoot and modify equipment and processes, support technicians and manufacturing leads, and help create maintenance procedures and operating documents. Qualified candidates will have CGMPs/ISO/FDA knowledge and SolidWorks/3D modeling skills.