Medical Device Process Engineer - Validation & Optimization

Intellectt Inc; Tempe (AZ); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Benefits

Job summary

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

The ideal candidate has experience in medical device manufacturing, process validation, statistical analysis, continuous improvement, and troubleshooting. The role focuses on process optimization, validation activities (IQ/OQ/PQ), and collaboration with Quality Engineering to support CAPA, change control, and Lean Six Sigma initiatives in a dynamic manufacturing

Qualifications

• Bachelor's degree in engineering required.
• 3+ years of manufacturing process engineering experience.
• Experience with FDA-regulated medical device manufacturing preferred.
• Hands-on experience with IQ/OQ/PQ and process validation.
• 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.
• Create process specifications, procedures, and equipment parameters.
• Execute IQ/OQ/PQ validation activities and supporting docs.
• Conduct process capability studies, DOE, and statistical analysis.
• Perform root cause analysis for defects and deviations.
• Collaborate with Quality Engineering on CAPA and change control.
• Implement Lean and Six Sigma initiatives.
• Support new product introduction, scale-up, and transfers.
• Develop and maintain PFMEA, control plans, and work instructions.
• Monitor yield, cycle time, stability, and performance.

Skills

Process Engineering

IQ/OQ/PQ

Process Validation

Minitab

DOE

SPC

PFMEA

CAPA

Manufacturing Optimization

ISO 13485

Education

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

Job description

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

The ideal candidate has experience in medical device manufacturing, process validation, statistical analysis, continuous improvement, and troubleshooting. The role focuses on process optimization, validation activities (IQ/OQ/PQ), and collaboration with Quality Engineering to support CAPA, change control, and Lean Six Sigma initiatives in a dynamic manufacturing