The Injection Molding Process Engineer II is responsible for leading process development, optimization, and continuous improvement activities within our injection molding operations.
This role supports our vision of becoming a center of excellence for medical‑grade molding by applying scientific molding principles, ensuring regulatory compliance, and driving high‑quality, data‑driven manufacturing performance.
Key Responsibilities:
Lead injection molding process development, optimization, and documentation activities to support production efficiency and product quality.
Apply scientific molding techniques to achieve consistent part quality, reduce defects, and optimize cycle times.
Conduct molding validations (IQ, OQ, PQ) in accordance with medical device regulatory requirements and internal quality standards.
Troubleshoot molding issues using structured problem‑solving tools, including root‑cause analysis and FMEA.
Maintain accurate and detailed process documentation to ensure traceability, audit readiness, and compliance.
Collaborate closely with Quality, R&D, Regulatory, and Production teams to support new product introductions and ongoing manufacturing improvements.
Support continuous improvement initiatives using SPC, DOE, Lean, and Six Sigma methodologies.
Review and interpret AutoCAD/SolidWorks drawings to support tooling, process setup, and engineering changes.
Qualifications:
Bachelor’s degree in Engineering, Chemical Engineering, or related technical field.
4-6 years of experience in plastic injection molding, preferably within the medical device industry.
Completion of a Scientific Molding course (e.g., RJG Fundamentals of Systematic Molding) preferred.
Strong understanding of medical‑grade polymers, molding equipment, and process control methodologies.
Experience working in regulated manufacturing environments.
Proficiency in data‑driven process monitoring and analysis.
Excellent communication and cross‑functional collaboration skills.
Preferred Attributes:
Continuous improvement mindset with demonstrated success implementing process enhancements.
High attention to detail and strong documentation discipline.
Commitment to product quality, patient safety, and ethical decision making.