NPI Manufacturing Engineer

We are seeking an NPI Manufacturing Engineer to support the introduction of complex electromechanical products into manufacturing. This role will collaborate with Design, Quality, and Operations teams to develop, qualify, validate, and improve manufacturing and test processes in a highly regulated environment.

• Support new product introduction from product development through manufacturing transfer and production readiness.
• Develop, characterize, and improve manufacturing processes for electromechanical products.
• Execute equipment qualification and process validation activities, including Installation, Operational, and Performance Qualification (IQ/OQ/PQ).
• Develop and execute test method validations and Design of Experiments (DOE).
• Conduct process risk assessments, including Failure Mode and Effects Analysis (FMEA).
• Troubleshoot manufacturing and test issues, investigate root causes, and implement corrective actions.
• Interpret engineering drawings and electrical schematics to support assembly, testing, and troubleshooting.
• Use multimeters, oscilloscopes, and other electrical test equipment to evaluate product and process performance.
• Prepare and maintain process documentation, validation protocols, reports, and work instructions.
• Collaborate across engineering, quality, and operations to improve manufacturing quality, efficiency, and reliability.

• Bachelor of Science degree in Mechanical, Industrial, Electrical, Biomedical Engineering, Robotics, Mathematics, or a related technical field.
• Experience with electromechanical systems and manufacturing process development.
• Hands-on experience with IQ/OQ/PQ, test method validation, DOE, and FMEA.
• Strong troubleshooting, root cause analysis, and problem-solving skills.
• Ability to interpret engineering drawings and electrical schematics.
• Experience using multimeters and oscilloscopes.
• Strong documentation, communication, and cross-functional collaboration skills.
• Ability to work onsite at both Milpitas and Santa Clara locations.

• 2 years of Experience with medical device quality systems or other regulated manufacturing environments.
• Knowledge of Statistical Process Control (SPC), Lean/Six Sigma, and continuous improvement tools.
• Familiarity with Product Lifecycle Management (PLM), Enterprise Resource Planning (ERP), or Manufacturing Execution Systems (MES).
• Experience with Python or other automation and scripting tools. Benefits:

  Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

  Health Insurance:

  Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

  Retirement Benefits:

  A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

  Paid Time Off (PTO):

  No PTO other than that required by applicable state and local laws