Manufacturing Engineer 1

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

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.

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