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Job Description
Job Summary
We are seeking a hands-on Process Engineer, Injection Molding to support and optimize manufacturing processes within a regulated medical device environment. This role is responsible for developing, validating, troubleshooting, and continuously improving injection molding processes to ensure the delivery of high-quality products while meeting Safety, Quality, Delivery, Cost, and People (SQDCP) objectives.
The successful candidate will work closely with Manufacturing, Quality, Tooling, Automation, and Engineering teams to drive process stability, improve Overall Equipment Effectiveness (OEE), support new product introductions, and implement robust scientific molding practices. This position also provides technical leadership and mentoring to Process Technicians and Operations personnel.
Key Responsibilities
Lead and support daily injection molding operations to achieve Safety, Quality, Delivery, Cost, and Productivity targets.
Develop, optimize, and sustain robust molding processes using Scientific Molding, Decoupled Molding, DOE, and statistical analysis techniques.
Troubleshoot molding, automation, tooling, material, and process-related issues to minimize downtime and improve process capability.
Drive continuous improvement initiatives focused on yield enhancement, waste reduction, cycle time optimization, and OEE improvement.
Establish, validate, and maintain process parameters, work instructions, standard operating procedures, and engineering documentation.
Support new product introduction, process transfers, qualification activities, and manufacturing scale-up projects.
Collaborate with Quality, Manufacturing, Tooling, and Automation teams to investigate non-conformances and implement corrective actions.
Program, troubleshoot, and support robotic systems, auxiliary equipment, and process-related manufacturing systems.
Monitor tool performance and coordinate mold maintenance, refurbishment recommendations, and lifecycle management.
Analyze process data and utilize Lean Manufacturing, Six Sigma, SPC, and other statistical tools to improve process performance.
Work closely with material and equipment suppliers to resolve technical issues and implement process improvements.
Ensure compliance with GMP, quality systems, environmental, safety, and regulatory requirements.
Provide technical coaching and mentorship to Process Technicians, Operators, and Manufacturing personnel.
Support engineering projects and perform other duties as assigned.
Qualifications & Experience
Required Qualifications
Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Plastics Engineering, Chemical Engineering, or a related engineering discipline.
Minimum 3-5 years of hands-on experience in injection molding process engineering within a manufacturing environment.
Strong understanding of injection molding principles, process optimization, and troubleshooting methodologies.
Experience supporting production environments with a focus on quality, productivity, and continuous improvement.
Proficiency in Microsoft Office applications including Excel, PowerPoint, and Word.
Strong analytical, problem-solving, and communication skills.
Preferred Qualifications
Experience in medical device, healthcare, pharmaceutical, electronics, precision manufacturing, or other regulated industries.
Knowledge of Scientific Molding, Decoupled Molding, Design of Experiments (DOE), SPC, and process validation methodologies.
Familiarity with Lean Manufacturing, Six Sigma, and OEE improvement…