Injection Molding Process Engineer

Injection Molding Process Engineer

Job Title: Injection Molding Process Engineer
Contract Duration: 6+ Months
Location: Greater Phoenix, Arizona
Work Arrangement: Onsite
Pay Rate: $70 $75/hr on C2C
Relocation: Accepted
Work Authorization: Any Visa
Experience: 7+ Years
Education: Bachelor's Degree
References: 2 Managerial References with LinkedIn Profiles Required

Position Overview

We are seeking an experienced Injection Molding Process Engineer for a hands-on engineering opportunity supporting injection molding process development, optimization, validation, and troubleshooting within a medical device manufacturing environment.

The engineer will analyze molding machine and tooling performance, support production operations, execute process improvements, and collaborate with internal teams and customers to resolve technical issues. This position will also support validation activities, protocol development, process characterization, and technical documentation as part of a broader manufacturing transition and expansion effort.

Strong communication and collaboration skills are essential, as the role requires regular interaction with operations, engineering, leadership, and external stakeholders.

Key Responsibilities

• Develop, optimize, characterize, and troubleshoot injection molding processes for medical device manufacturing.

• Apply hands-on scientific molding principles to improve molding processes, equipment performance, and tooling.

• Analyze injection molding machine and tooling performance and identify opportunities for process improvement.

• Troubleshoot molding equipment, tooling, and process-related issues and implement effective corrective actions.

• Support production operations by providing technical expertise and resolving manufacturing process issues.

• Develop and execute Design of Experiments (DOE) to evaluate and optimize process parameters.

• Perform DOE design and statistical analysis using Minitab.

• Conduct process characterization activities to establish robust and repeatable manufacturing processes.

• Support and execute IQ/OQ/PQ validation activities.

• Develop validation protocols and associated technical documentation.

• Apply statistical process capability methodologies, including CpK and PpK, to evaluate process performance.

• Perform root cause analysis for process, equipment, tooling, and quality issues.

• Develop and maintain control plans and inspection plans.

• Prepare clear and accurate technical documentation, reports, protocols, and process records.

• Support manufacturing transition and expansion activities.

• Collaborate with Operations, Quality, Engineering, Manufacturing, and other cross-functional teams.

• Work directly with customers and external stakeholders to understand and resolve technical issues.

• Communicate project status, technical findings, risks, and recommendations to leadership and stakeholders.

• Identify and implement process improvements that enhance quality, efficiency, consistency, and manufacturing performance.

Required Qualifications

• Bachelor's Degree in Engineering or a related technical discipline.

• 7+ years of relevant engineering experience.

• Strong hands-on experience with scientific molding and injection molding process development.

• Proven experience troubleshooting and optimizing injection molding equipment and tooling.

• Strong experience with DOE design and analysis using Minitab.

• Experience with process characterization and statistical analysis.

• Hands-on experience with IQ/OQ/PQ validation.

• Strong knowledge of statistical process capability methodologies, including CpK and PpK.

• Experience performing root cause analysis and developing effective corrective actions.

• Experience developing and maintaining control plans and inspection plans.

• Strong technical documentation and protocol writing skills.

• Excellent written and verbal communication skills.

• Ability to work effectively with operations, engineering, leadership, customers, and other stakeholders.

• Experience working in a regulated medical device manufacturing environment.

Technical Skills

• Injection Molding Process Development

• Scientific Molding

• Injection Molding Equipment & Tooling

• Process Optimization

• Process Troubleshooting

• Process Characterization

• Design of Experiments (DOE)

• Minitab

• IQ/OQ/PQ Validation

• Statistical Process Capability

• CpK / PpK

• Root Cause Analysis

• Control Plans

• Inspection Plans

• Technical Documentation

• Protocol Development

• Manufacturing Process Improvement

Preferred / Nice-to-Have Skills

• Experience with manufacturing robotics and automation.

• Knowledge of Lean Six Sigma methodologies.

• Experience with continuous improvement initiatives.

• Metrology knowledge within a regulated manufacturing environment.

• Experience supporting manufacturing transitions, expansions, or new process implementations.

Domain Experience

Experience within a regulated medical device manufacturing environment is highly relevant to this position. Candidates should understand the importance of process validation, documentation, quality, statistical process control, and maintaining robust manufacturing processes.

Ideal Candidate

The ideal candidate is a senior-level Injection Molding Process Engineer with extensive hands-on scientific molding experience and a strong background in process development, optimization, validation, and troubleshooting. The candidate should be comfortable working directly on the manufacturing floor, analyzing molding equipment and tooling, conducting DOE and process characterization, and communicating technical recommendations to both internal and external stakeholders.

Strong candidates should have direct experience with Scientific Molding + Minitab + DOE + IQ/OQ/PQ + CpK/PpK + medical device manufacturing.