Manufacturing Engineer 1

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

Job Summary:

Hologic is seeking a Manufacturing Engineer responsible for providing engineering support services including evaluation, purchase, installation, and qualification of new manufacturing equipment and sustainment of existing equipment and processes.

Duties and 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, PM’s and change controls

Qualifications:

• 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

Education and experience:

• BA or BS degree
• 1-2 years of related industry experience

Onsite (in San Diego, CA site 5x/week)

Additional Info:

The annualized base salary range for this role is $63,600 to $99,500 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.