Manufacturing Engineer

I3 INFOTEK INC; California (MO); On-site; USD 90,000 - 120,000; Full time

Job summary

I3 INFOTEK INC is seeking an engineering professional with proven experience in medical devices and FDA regulatory compliance. The role emphasizes design, testing and qualification of test equipment used in development and manufacturing.

You will conduct evaluations, feasibility studies, functional testing, data analysis and write protocols and reports, while performing troubleshooting on breadboards, hybrids and prototype hardware to ensure robust performance.

Qualifications

• Experience in medical devices and FDA regulation compliance.
• 3+ years in test equipment design, construction, and evaluation.
• Ability to write protocols and reports for testing activities.
• Troubleshooting on breadboards, hybrids, and prototype hardware.
• Familiarity with measurement tools and standard office software.

Responsibilities

• Conduct engineering evaluations, feasibility studies, and functional testing.
• Perform data analysis, fixture design/qualifications, and process validations.
• Write protocols and reports for testing activities.
• Troubleshoot and isolate faults on breadboards, hybrids and prototype hardware.

Skills

Medical device experience

Test equipment design

Functional testing

Data analysis

Process validations

Troubleshooting

Technical writing

Tools

Breadboards

Prototype hardware

Precision measurement tools

Production equipment

Job description

• Experience working on medical devices and demonstrated ability to comply with FDA regulations are a must.
• Minimum 3 years of relevant experience in test equipment design, construction, and evaluation.
• Conducts engineering evaluations, feasibility studies, functional testing, data analysis, fixture design / qualifications, process validations and writes the protocols and reports.
• Performs troubleshooting and fault isolation on breadboards, hybrids, and prototype hardware.
• Utilizes production equipment, test instruments, precision measurement tools, and standard office software as required.