Manufacturing Engineer I — Equipment & Process Optimization

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

Job summary

Hologic, Inc. is seeking a Manufacturing Engineer to provide engineering support for evaluating, purchasing, installing and qualifying new equipment, and sustaining existing equipment and processes.

Onsite in San Diego, CA five days a week, you will troubleshoot, modify, and support engineering efforts across manufacturing lines. The role emphasizes CGMP/ISO 13485/FDA 21 CFR 820 knowledge, Windows-based software, and proficiency with SolidWorks or Pro/E, MS Office and MS Project.

Qualifications

• Bachelor's degree in a related field required.
• 1–2 years of related industry experience preferred.
• Knowledge of CGMPs, ISO 13485 and FDA 21 CFR 820 is expected.

Responsibilities

• Troubleshoot and modify equipment and processes.
• Support equipment mechanics, technicians and manufacturing leads.
• Create and modify equipment maintenance procedures.
• Write and review operating procedures, documents and reports.
• Perform equipment, process and product performance testing.
• Assist with equipment installation, operation and IQ/OQ/PQ validations.
• Review and approve calibration datasheets, work orders, PMs and change controls.

Skills

Microprocessor controls knowledge

Manufacturing automation knowledge

Regulatory knowledge CGMP ISO 13485 21

Windows familiarity

MS Office / MS Project familiarity

Education

Bachelor's degree

Tools

SolidWorks

Pro/E

MS Office

MS Project

Job description

Hologic, Inc. is seeking a Manufacturing Engineer to provide engineering support for evaluating, purchasing, installing and qualifying new equipment, and sustaining existing equipment and processes.

Onsite in San Diego, CA five days a week, you will troubleshoot, modify, and support engineering efforts across manufacturing lines. The role emphasizes CGMP/ISO 13485/FDA 21 CFR 820 knowledge, Windows-based software, and proficiency with SolidWorks or Pro/E, MS Office and MS Project.