Title : NPI Manufacturing Engineer Location : Northern CA Duration : 12months Role Overview: This opportunity focuses on supporting the introduction of new products into manufacturing within a highly regulated environment. The engineer will collaborate with design, quality, and operations teams to develop, validate, and sustain manufacturing and test processes for complex electromechanical products. Responsibilities include process characterization, equipment qualification, validation activities, root cause investigations, and continuous improvement initiatives. The role offers significant cross-functional exposure and the opportunity to influence manufacturing strategy throughout the product development lifecycle.
- Required Skills:
- Experience with electromechanical systems, manufacturing process development, and troubleshooting/root cause analysis.
- Hands-on experience with process validation activities (IQ/OQ/PQ), test method validation, DOE, and risk assessments such as FMEA.
- Ability to interpret engineering drawings and schematics and utilize electrical test equipment including multimeters and oscilloscopes.
- Nice to Have:
- Experience working within medical device quality systems and regulated manufacturing environments.
- Knowledge of SPC, Lean/Six Sigma methodologies, and continuous improvement tools.
- Familiarity with PLM, ERP, or MES systems and automation/scripting tools such as Python.
- Education: Bachelor of Science degree in a technical field (Mechanical Engineering, Industrial Engineering, Electrical Engineering, Biomedical Engineering, Robotics, Mathematics, or similar) required.