Process Engineer

• ◆Monitor and analyze injection molding processes to identify opportunities for optimization and improvement.
• ◆Conduct process audits, collect data, and perform statistical analysis to assess process performance and variability.
• ◆Investigate and troubleshoot molding defects, part quality issues, and process deviations using Root Cause Analysis (RCA) methodologies.
• ◆Implement corrective and preventative actions to address process issues and prevent recurrence.
• ◆Work closely with the Tooling Engineer and Maintenance Technician to ensure proper maintenance and upkeep of injection molds, machinery, and auxiliary equipment.
• ◆Coordinate mold changes, equipment upgrades, and repairs to minimize downtime and optimize production efficiency.
• ◆Lead or participate in continuous improvement projects aimed at enhancing process capabilities, reducing cycle times, and improving quality and consistency.
• ◆Implement Lean Manufacturing principles and methodologies to streamline workflows, eliminate waste, and increase productivity.
• ◆Maintain accurate documentation of process parameters, Standard Operating Procedures (SOPs), and validation protocols.
• ◆Generate reports, analyze data trends, and present findings to management and stakeholders as needed.
• ◆Collaborate with cross-functional teams, including engineers, technicians, and quality assurance.

& Skills

• ✓Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a related field.
• ✓1+ years of experience in Injection Molding processes required, preferably in the medical device manufacturing industry.
• ✓Knowledge of MS Office Programs such as Excel, Word, PowerPoint, etc.
• ✓Familiar with ISO regulated environment; highly regulated industry experience such as medical device, automotive, or aerospace is preferred.
• ✓Knowledge of SOPs, Work Instructions, and ISO 13485 standards preferred.
• ✓Actively performs and understands Good Documentation Practices (GDP).
• ✓Knowledge of Quality Management Systems (QMS) and regulatory standards such as ISO 13485 and FDA 21 CFR Part 820.
• ✓Knowledge of CAD/CAM software such as SolidWorks, AutoCAD, or Pro/ENGINEER for designing and modeling injection molds and tooling components.
• ✓Proven track record of optimizing injection molding processes, troubleshooting issues and driving continuous improvement initiatives.
• ✓Knowledge of injection molding principles, including mold design, material selection, processing parameters, and tooling considerations.
• ✓Proficiency in process optimization techniques, Design of Experiments (DOE), and statistical analysis to improve product quality, cycle times, and yields.
• ✓Familiarity with scientific molding principles and advanced molding technologies (e.g., gas-assisted molding, multi-component molding)
• ✓Knowledge of regulatory

and standards governing medical device manufacturing, including FDA regulations and ISO 13485 quality management systems.

• ✓Experience in implementing and maintaining compliant manufacturing processes and documentation.
• ✓Strong analytical and problem-solving skills to diagnose root causes of molding defects, process variations, and non-conformances.
• ✓Ability to develop and implement effective solutions to address process issues and improve overall process capability and efficiency.
• ✓Ability to communicate technical concepts and recommendations clearly and effectively to stakeholders at various levels of the organization.
• ✓RJG Master Molder Certification, Society of Plastics Engineers (SPE) Injection Molding Certificate Program, Six Sigma, Certified Injection Molding Professional (CIMP), or other related certifications preferred.