Process Engineer

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

Role: Process Engineer
Location: Arizona
Rate: $40/hr - 45/hr
Experience: 3 7 Years (Preferred)
Industry: Medical Device Manufacturing
Department: Manufacturing / Process Engineering

Position Summary:

We are seeking a Process Engineer to develop, validate, optimize, and maintain manufacturing processes used in the production of medical devices and components.

The ideal candidate will have experience in medical device manufacturing processes, process validation, statistical analysis, continuous improvement, and manufacturing troubleshooting.

Key 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.

Required Qualifications:

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

Key Skills:

Process Engineering, IQ/OQ/PQ, Process Validation, Minitab, DOE, SPC, PFMEA, CAPA, Manufacturing Process Optimization, ISO 13485.

Benefits:

• Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Equal Employment Opportunity:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.