Extrusion Engineer is responsible for new process development, legacy product process improvements, project engineering, technical sales support, and other engineering related support functions to support organizational growth and profitability. Will function as internal expert on equipment and processes, process controls and process validations to ensure a safe, stable and repeatable manufacturing platform for products within an FDA 21 CFR and ISO 13485 regulated environment.
The Extrusion Engineer performs functions to provide engineering support to manufacturing, quality and sales operations for assigned products. Identifies extrusion requirements, writing specifications, analyzing system performance, designing for spec compliance, documenting manufacturing processes, tracking and expediting products through phases of validation and manufacturing, while working within limits of established policy.
- Provides engineering support for extrusion processes and tooling. Supports internal manufacturing, quality and sales operations for all assigned projects; Provides research and development support for all assigned processes, presents research as needed to clients; Functions as internal expert on manufacturing platforms within the organization. Investigates process improvements and/or alternatives. Recommends and implements new processes and process improvements.
- Leads, directs, influences and coordinates the work of major projects with responsibility for project objectives, completion dates, and technical specifications. Develop work breakdown structures and lead others in the completion of milestones and tasks within the project plan.
- Exercises judgment to define manufacturing requirements and processes, tests, troubleshoots, repairs, and validates equipment. Documents all work in accordance with applicable CMP QMS procedures.
- Develops, documents, plans, and is responsible to oversee the executes process validation protocols through IQ,OQ,PQ on new processes and legacy process changes. Responsible for all engineering activities through product launch.
- Evaluates and analyzes results, develops design improvements and implements them, develops test procedures, test specifications, and supporting documentation - Troubleshoots and problem solves using test equipment.
- Utilizes structured problem solving techniques such as cause and effect diagrams; 8D; and DOE to ensure root cause identification and effective RCCM and CAPA implementation
- Guides and develops other personnel by precedent and within the limits of all established procedures and regulatory requirements. Analyzes product, customer, and regulatory requirements to ensure processes, tools, fixtures and equipment requirements are properly translated and implemented into documentation.
- Reviews potential product modifications and consults with customers, suppliers, and others to determine the best approach. Builds prototypes and ensures product meet customer’s requirements and expectations. Documents changes and creates reports to be shared with customers and document control.
- Collaborates with Quality Engineering to define quantitative parameters for quality inspection and testing as required per customer and regulatory quality requirements.
- Determines safety limits/requirements of production equipment and set appropriate limitations and safeguards to ensure safe operation.
- Investigates equipment or process problems, devises methods of repair, and makes adjustments or directs related efforts of others. Includes and is not limited to documenting what was done and training maintenance personnel and production associates to eliminate repeat issues.
- Attends and participates in a variety of meetings and task force groups to integrate activities, and communicate issues, obtain approvals, resolve problems and maintain high level of knowledge pertaining to new developments, requirements, and policies.
- Leads and participates in Kaizen activity.
- Utilize systemic thinking to lead and participate in IPO (input-process-output) process design to ensure all stakeholders are engaged in new process development.
- Works with Operations personnel to schedule engineering activities requiring resources outside the engineering team.
- Assists Quality in customer complaint responses; CAPA’s; QANN’s (Quality Assurance Nonconformance Notice) and other related problem solving activities.
- Train appropriate personnel on new equipment, processes, and changes to existing processes.
- Develops new engineering masters in ERP system
- Performs other engineering related tasks as required.