Hamilton Medical, Inc. is looking for a Senior Process Engineer who specializes in injection molding that will be responsible for developing, integrating, and sustaining injection molding operations. The primary focus of this role is to plan and implement injection molding lines, lead efforts to manage capacity expansion, and drive continuous improvement projects in safety, quality, delivery, and cost of injection molding. This role also owns performance and reliability of molding equipment and the development of optimal process parameters. Project work includes coordinating with external suppliers to design and procure molds, performing detailed cost analysis to deliver the best business case, and leading offers to vertically integrate components which are currently outsourced. A leading candidate collaborates exceptionally with multiple teams (Production, Maintenance, Supply Chain, Quality, Finance) and is regularly involved in Cross-functional project management.
Other Job Duties Include:
- Production Line Setup and Support:
- Design/modify precision medical molding & inspection lines and equipment
- Provides expertise in process parameter development for optimal equipment run conditionals for high and stable yield
- Manage start-up, debug, and commission of new manufacturing processes
- Equipment life cycle management including upgrades, replacement, and decommissioning
- Drive continuous improvement activities again measurable targets in quality, delivery, and cost
- Provide technical support/troubleshooting to injection molding operations
- Manage and execute new mold validations through our internal processes including writing and executing IQ/OQ/PQ protocols to qualify new equipment and processes
- Support product life cycle management including product design changes, material changes, Supplier Notice of Change (SNC) assessments, specification changes, etc.
- Project Management:
- Manage capital projects both directly and through coordinating engineers
- Manage multiple projects with minimal supervision
- Prepare estimates for various tasks and projects
- Technical Documentation and Regulatory Compliance:
- Demonstrate proactive communication and problem solving
- Responsible for always adhering to FDA regulations
- Adhering to and maintaining all department Standard Operating Procedures (SOPs), forms, and logbooks
- Generate technical documents, reports, equipment specifications, and interpret technical drawings/schematics
- Establish, maintain, and ensure compliance to process Control Plan per PFMEA