Process Engineer

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

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.

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.