NPI Manufacturing Engineer

Intellectt Inc; Milpitas (CA); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Health Insurance

401(k) Retirement Plan

Paid Time Off

Job summary

Intellectt Inc. is seeking an NPI Manufacturing Engineer to support the introduction of complex electromechanical products into manufacturing.

The role collaborates with Design, Quality, and Operations to develop, qualify, validate, and improve manufacturing and test processes in a highly regulated environment. The role focuses on new product introduction, process development, equipment qualification, DOE, and FMEA, with onsite work at Milpitas and Santa Clara.

Qualifications

• Bachelor’s degree in engineering or related technical field.
• Experience with IQ/OQ/PQ, test method validation, DOE, and FMEA.
• Ability to interpret engineering drawings and electrical schematics.
• Onsite work at Milpitas and Santa Clara locations.

Responsibilities

• Support new product introduction from development through manufacturing transfer and production readiness.
• Develop, characterize, and improve electromechanical manufacturing processes.
• Execute IQ/OQ/PQ qualification and process validation activities.
• Develop and execute test method validations and DOE.
• Conduct process risk assessments including FMEA.
• Troubleshoot manufacturing/test issues and implement corrective actions.
• Interpret drawings/schematics to support assembly, testing, troubleshooting.
• Use meters/scopes to evaluate product/process performance.
• Prepare and maintain process docs, validation protocols, and work instructions.
• Collaborate across engineering, quality, and operations to improve quality, efficiency, and reliability.

Skills

IQ/OQ/PQ

DOE

FMEA

Troubleshooting

Root cause analysis

Documentation

Communication

Collaboration

Education

BSc in Mechanical / Industrial / Electrical / Biomedical Engineering

Tools

Multimeters

Oscilloscopes

Python / automation scripting

Job description

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.

Key Responsibilities

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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