Manufacturing Engineer

Job Title:

Manufacturing Engineer Salary:

$85-$100K + 7.5% bonus

Location:

San Diego, CA Duration:

PERM Shift:

M-F 1 st Shift (exact hours, TBD)

Job Summary:

We are 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.

Essential Duties and Responsibilities:

The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs. Provides engineering support for troubleshooting, modifying equipment and processes Supports equipment mechanics, technicians and manufacturing leads Create and/or modify 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

Physical Demands:

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Sit; use hands to finger, handle or feel objects, tools, or controls. Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. Lifting/pushing/pulling and carrying products weighing up to 45 pounds Potential Exposure to moving mechanical parts, vibration and/or moderate noise levels. Potential Exposure to hazardous chemicals or other materials. Safety Shoes compliant with site specific policies/procedures must be worn in designated areas

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:

BA or BS degree LEAN & Six Sigma certification preferred but not required

Experience:

Minimum 2-4 years of related industry experience