Manufacturing Engineer

Manufacturing Engineer

Location:

San Diego, CA

Onsite Flexibility:
Onsite

Contract Details

• Position Type:
  Contract
• Contract Duration: 13 months
• Pay Rate: $70.00–$90.00 / Hour (USD)
• Work Authorization:
  Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Our client is seeking a Manufacturing Engineer responsible for providing engineering support services including automation development, evaluation, purchase, installation, and qualification of new manufacturing equipment. This role is based at the San Diego Campus, which is the center of the Diagnostics Solutions Division, with a focus on Molecular Diagnostics. The majority of products produced from the San Diego site are utilized onboard innovative and fully automated sample-to-result instrument systems.

The consumables required for patient testing are integral to the business. The business growth projections and new product development projects provide unique opportunities to enable the company's Purpose, Passion, and Promise to empower global health advancements.

• Manage the design, acquisition, installation, and commission of mechanical/electrical equipment, systems, and parts to support manufacturing
• Perform process development and transfers from Engineering to Manufacturing
• Provide technical engineering support for repairing, troubleshooting, and modifying equipment and systems
• Mechanical understanding of custom automation systems and their impact with consumables
• Establish and challenge manufacturing processes
• Functional testing on internal automated manufacturing equipment
• Execute engineering functions such as:
  Design Reviews, Measurement Systems Analysis, Design of Experiments, feasibility studies, process development, acceptance testing, and risk management
• Understand drawing functions including GD&T
• Develop inspection and measurement techniques
• Analyze advanced statistics to confirm or reject hypothesis
• Analyze test results, provide recommendations, and author summary reports
• Independently lead the creation of RFQ/URS documentation for injection molds and/or consumables automation systems
• Continuously improve internal and external supplier processes to reduce the time to market, enhance product quality, and decrease costs
• Develop and/or implement continuous improvement ideas and participate in the strategic Operations plans
• Manage outside vendors with establishing relationships to provide equipment proposal, user requirement specification, development, installation, qualification, and sustaining support of equipment and processes
• Manage qualifying and changes in raw materials, vendors, and perform investigations for non-conformance events
• Design and implement automated solutions to manufacturing challenges
• Provide QS validation input and support for new equipment and process validations including reviewing and executing Installation, Operation, and Performance Qualification Validations; including writing final reports

• Working knowledge of microprocessor controls, utility distribution systems, and process engineering
• Biotech / Medical Device / Pharmaceutical industry experience
• Basic knowledge of manufacturing automation systems and best design practice
• High proficiency with MS Office, MS Project, and MS Share Point
• High proficiency with Minitab or other statistical analysis software
• Working knowledge of manufacturing automation systems and design practices
• Working knowledge of cGMP, GAMP, ISO 13485, and FDA 21 CFR, Part 820

• BA or BS degree, preferred in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Quality Engineering, Biomedical Engineering, or Validation Engineering
• Lean Manufacturing and/or Six-Sigma Certification preferred but not required
• Certified Quality Engineering Certification preferred but not required

• 10 years of Biotech / Medical Device / Pharmaceutical industry experience

• Sit; use hands to finger, handle, or feel objects, tools, or controls
• Stand; walk; reach with hands and arms; and stoop, kneel,…