Process Validation Engineer
Responsibilities:
- Development of New Injection Molding Processes using scientific molding principles.
- Lead complete IQ/OQ/PQ validation activities of both thermoplastic and silicone injection molds working
- with all stakeholders including Engineering, Production and Quality
- Troubleshoot molding processes to mitigate production defects and or improve efficiency
- Participate in design reviews of new tooling and equipment working with both external and internal
- injection mold makers
- Lead technology improvements that advance our molding processes for new and existing products.
- Prepare complete and accurate records/documentation of assigned project activities per the established
- Quality System and Validation Guidelines
- Participate in regular project meetings, publishes timely project updates, and follows-up continuously
- on all open critical path items
- Generate and maintain documentation for applicable internal processes and procedures, inspection
- criteria, Bill of Materials, Validation Protocols/Reports and other manufacturing and quality records
- Identify, initiate and implement technology improvements, which increase productivity and reduce
- scrap/reject rates through effective training of production personnel and process enhancements
- Maintain and improve product quality by performing and documenting robust root cause investigations
- and implementing effective corrective and preventive actions
- Develop and leverage product knowledge to ensure Critical Quality Attributes (CQAs) are consistently
- met
Requirements:
- Bachelor's degree in engineering or equivalent years of directly related experience (or high school +8yrs.
- Assoc.
- +4 yrs.; Scientific Molding Certifications (master molder) +2yrs)
- Minimum: 2 years' experience in high volume molding and manufacturing environment
- Preferred: 2 years' experience in medical device manufacturing or other highly regulated industry
- Working knowledge of Validation processes (IQ/OQ/PQ)
- Technical expertise in injection molding of thermoplastics related to Design for Manufacturability of
- molds, processing of thermoplastics, robotics, automation and hot runner system
- Comprehensive knowledge and thorough understanding of troubleshooting techniques for the
- injection molding process, machine, robot and auxiliaries.
- Experience with advanced processing techniques (eDart), robot programming, hot runner molds,
- tooling issue diagnostics, molding machine diagnostics, central material handling systems and color
- blending.
- Processing knowledge of Polycarbonate, Acrylic, ABS, Polysulfone, and various commodity resins
- Familiar with SPC methodologies and the scientific molding process.
- Data driven, disciplined, objective and detail oriented.
- Ability to read and interpret part and mold drawings
- Ability to work with minimal supervision and/or guidance
- Familiarity with statistical problem solving techniques
- Excellent organization and communication skills.
- Knowledge of FDA regulations and other international compliance standards
- Competency in the following software: MS Project, Excel, Word, PowerPoint