Medical Device Process Engineer — Validation & Lean

Intellectt INC; Phoenix (AZ); On-site; USD 55,000 - 62,000; Full time

Benefits offered by this job

Benefits

Job summary

Intellectt Inc. in Arizona is seeking a Process Engineer to develop, validate, optimize, and maintain manufacturing processes for medical devices and components.

The role emphasizes hands-on process validation, statistical analysis, and continuous improvement to ensure quality and efficiency. The ideal candidate will have experience with process validation (IQ/OQ/PQ), Lean Six Sigma, CAPA, and ongoing troubleshooting to drive yield, cycle time, and process stability in FDA-regulated

Qualifications

• Bachelor's degree in Mechanical/Manufacturing/Industrial/Biomedical/Chemical Engineering or related field.
• 3+ years of manufacturing process engineering experience.
• Experience in FDA-regulated medical device manufacturing preferred.
• Hands-on process validation (IQ/OQ/PQ) experience.
• Knowledge of SPC, DOE, process capability analysis, and Minitab.

Responsibilities

• Develop and optimize manufacturing processes for medical device production.
• Support automated assembly, injection molding, bonding, welding, or other device manufacturing operations as applicable.
• Develop process specifications, manufacturing procedures, and equipment operating parameters.
• Execute process validation activities, including IQ/OQ/PQ and supporting documentation.
• Conduct process capability studies, statistical analysis, and DOE activities.
• Perform root cause analysis for manufacturing defects, scrap, and process deviations.
• Collaborate with Quality Engineering to support CAPA, nonconformance investigations, and change control.
• Implement Lean Manufacturing and Six Sigma process improvement initiatives.
• Support new product introduction, manufacturing scale-up, and process transfers.
• Develop and maintain process FMEAs, control plans, and work instructions.
• Monitor production yield, cycle time, process stability, and manufacturing performance.

Skills

Process Engineering

IQ/OQ/PQ

Process Validation

Minitab

DOE

SPC

PFMEA

CAPA

Manufacturing Process Optimization

ISO 13485

Education

Bachelor's degree in Mechanical/Manufacturing/Industrial/Biomedical/Chemical Engineering

Job description

Intellectt Inc. in Arizona is seeking a Process Engineer to develop, validate, optimize, and maintain manufacturing processes for medical devices and components.

The role emphasizes hands-on process validation, statistical analysis, and continuous improvement to ensure quality and efficiency. The ideal candidate will have experience with process validation (IQ/OQ/PQ), Lean Six Sigma, CAPA, and ongoing troubleshooting to drive yield, cycle time, and process stability in FDA-regulated