Arizona Medical Device Process Engineer | Validation & Lean

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

Benefits offered by this job

Benefits

Job summary

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

The role requires hands-on process validation, IQ/OQ/PQ, and strong problem-solving skills for manufacturing troubleshooting. The ideal candidate will have 3+ years of experience in medical device manufacturing, proficiency with Minitab and SPC, and familiarity with ISO 13485 and FDA QMSR requirements.

Qualifications

• Bachelor's degree in engineering (Mechanical, Manufacturing, Industrial, Biomedical or Chemical).
• 3+ years of manufacturing process engineering experience.
• Experience in FDA-regulated medical device manufacturing preferred.
• Hands-on experience in process validation and IQ/OQ/PQ.
• Knowledge of SPC, DOE, process capability analysis, and Minitab.
• Familiarity with ISO 13485, FDA QMSR, and medical device quality requirements.
• Strong troubleshooting, technical writing, and process improvement capabilities.

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

DOE

SPC

PFMEA

CAPA

Manufacturing Process Optimization

ISO 13485

Education

Bachelor's degree in Mechanical Engineering

Tools

Minitab

Job description

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

The role requires hands-on process validation, IQ/OQ/PQ, and strong problem-solving skills for manufacturing troubleshooting. The ideal candidate will have 3+ years of experience in medical device manufacturing, proficiency with Minitab and SPC, and familiarity with ISO 13485 and FDA QMSR requirements.