Published: December 18, 2017
- Follow all GMP’s as defined by company practices, policies and SOP’s to ensure that FDA regulations are met.
- Focus on daily customer and process related issues to improve quality, on time delivery and process efficiencies. Implement corrective actions where appropriate.
- Plan, lead, execute and complete projects to improve productivity and quality through proper investigation and data driven six sigma principals.
- Identify optimal conditions by evaluating factors such as material temperature, flow rate, pressure, and cooling rate during molding process and most important during the development of molding process.
- Design plastics or injection-mold fabrication processes.
- Create and improve injection-mold machinery.
- Develop molding process manufacturing processes.
- Analyze manufacturing data and suggest improvements.
- Analyze production and machinery line.
- Ensure quality output of molded components.
- Develop and design engineered plastic parts, insert molded parts and assemblies.
- Establish the parameters for an optimal molding environment.
- Analyze quality control and correct flaws.
- Review existing validation reports.
- Create new reports and verifications.
- Analyze mold flow, part advisor analysis, finite element analysis, and stress/fatigue analysis on plastics
- Provide Engineering support for all manufacturing events.
- Support and develop validation protocols and reports (IQ/OQ/PQ) and provide objective evidence that equipment, processes, test methods and product meet requirements and are complaint with applicable regulations.
- Close communication with customers, QA, suppliers and product development teams on project matters, material issues, tooling and fixture design, process capability studies, and product quality issues for existing processes, products and related projects.
- Design and procure process tooling.
- Develop process documentation and training materials for new processes, materials, and equipment, including drawings, protocols, completion reports and specifications.
- Conduct research and development testing and validation to determine effectiveness and compliance to quality standards for the manufacturing processes. Confirm conformance to engineering designs and methodologies and verify overall safety. Prepare reports on these activities.
- Utilize proven lean manufacturing based analytical and troubleshooting/problem solving abilities to identify opportunities for cost reduction, lead-time reduction, inventory reduction and quality improvement through defect reduction.
- Supervisor Processing and Mold Set Up Technicians, set priorities for the day, troubleshoot and manage any personnel or mold issues.
- Bachelor’s Degree in Engineering; preferably in plastics engineering, polymer science or materials science.
- Minimum 10 years’ experience working as a process engineer with previous experience in medical devices
- Previous experience or training with project management techniques.
- Technical experience injection molding / plastics processing and tooling.
- Experience with Scientific Injection Molding Principles in a related manufacturing environment.
- Experience with automation, robotics, PLCs and inspection systems
- Demonstrated oral and written/technical document creation and presentation skills.
- Familiarity with statistical problem solving and six sigma techniques.
- Experience with validation protocols and reports, DOE, FMEA risk assessments, technical report authoring, strong statistical data analysis.
- Attention to detail and able to work independently and on a team with little supervision.
- Six Sigma Green or Black Belt certification
- Lean Manufacturing Green or Black belt certification