NPI Manufacturing Engineer

United Pharma; California (MO); On-site; USD 90,000 - 150,000; Full time

Job summary

United Pharma is seeking an experienced NPI Manufacturing Engineer to support introduction of new products in a highly regulated environment. You will work with Design, Quality, and Operations to develop, validate, and improve electromechanical manufacturing and test processes.

The role requires hands-on testing, strong problem solving, and cross-functional collaboration across the product lifecycle. Knowledge of IQ/OQ/PQ, DOE, FMEA, and SPC is preferred; Python scripting or automation skills

Qualifications

• Experience in medical device manufacturing or regulated environments.
• Experience performing IQ/OQ/PQ, DOE, and FMEA risk assessments.
• Ability to interpret drawings and schematics.
• Hands-on testing with multimeters and oscilloscopes.

Responsibilities

• Support NPI and manufacturing process development.
• Develop, validate, sustain manufacturing and test processes.
• Execute IQ/OQ/PQ, DOE, and FMEA risk assessments.
• Troubleshoot electromechanical systems and lead RCA.
• Interpret engineering drawings and technical docs.
• Perform hands-on testing with electrical test equipment.
• Drive continuous improvement and manufacturing readiness.
• Collaborate with cross-functional teams through product life cycle.

Skills

NPI process development

Root cause analysis

Cross-functional collaboration

Electrical testing

DOE

FMEA

Tools

Python

PLM/ERP/MES familiarity

Job description

We are looking for an experienced NPI Manufacturing Engineer to support the introduction of new products into a highly regulated manufacturing environment. The role will work closely with Design, Quality, and Operations teams to develop, validate, and improve manufacturing and test processes for complex electromechanical products.

Key Responsibilities:

• Support New Product Introduction (NPI) and manufacturing process development.
• Develop, characterize, validate, and sustain manufacturing & test processes.
• Execute IQ/OQ/PQ, test method validation, DOE, and FMEA/risk assessments.
• Troubleshoot electromechanical systems and lead root cause investigations.
• Interpret engineering drawings, schematics, and technical documentation.
• Perform hands-on testing using multimeters, oscilloscopes, and electrical test equipment.
• Drive continuous improvement, process optimization, and manufacturing readiness.
• Collaborate with cross-functional teams throughout the product development lifecycle.

Preferred Experience:

• Medical device / regulated manufacturing experience.
• Knowledge of SPC, Lean/Six Sigma, and continuous improvement.
• Familiarity with PLM, ERP, or MES systems.
• Experience with automation or scripting tools such as Python.