Process Engineer

Intellectt INC; Arizona City (AZ); Presencial; USD 55.000 - 62.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Benefits

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Process Engineering

IQ/OQ/PQ

DOE

SPC

PFMEA

CAPA

Manufacturing Process Optimization

ISO 13485

Educación

Bachelor's degree in Mechanical Engineering

Herramientas

Minitab

Descripción del empleo

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.