Process Engineer - Extrusion
Position Summary: The Medical Tubing Extrusion Engineer will be responsible for designing, developing, and implementing new extrusion processes for medical tubing products. This includes qualifying raw materials, designing dies and tooling, and optimizing process parameters to meet product specifications and quality standards. The engineer will also troubleshoot and resolve production issues related to extrusion processes, and continuously improve existing processes to increase efficiency and reduce costs.
Key Responsibilities:
- Selection of processes and definition of article specific production parameters
- Provide technical input to achieve reproduceable production runs of tubing in accordance with drawings/specifications
- Design specifications and development of extrusion tooling and machinery for secondary processes (e.g. printing, cutting, winding equipment)
- Coordination and responsibility for extrusion process development projects
- Responsibility for in-time supply of machines, tooling, and processes to the production site
- Market analysis on new extrusion techniques, evaluation and implementation of new extrusion technologies
- Technical input to the (TVK/RPK) calculation process for new tubing articles
- Support of the continuous improvement process in the plant
- Optimization of production costs and improvement of quality of tubing articles in serial production
- Evaluation of customer specifications regarding technical feasibility
- Support of AT team and sales with regard to design of production concepts and tubing developments
- Design of specification books for extrusion equipment as support for purchasing department
- Conduct trial extrusions in the plant in order to generate samples for customers
- Support of operating personnel in case of production problems
- Process validation of extrusion machinery
- FAT of tooling, machines, and other extrusion equipment and approval of payment to the suppliers
- Evaluation runs for new tooling
- Collaborate with cross-functional teams, including R&D, manufacturing, and quality control
Qualifications/Skills:
- Experience with statistical process control (SPC) and process optimization
- Strong problem-solving and analytical skills
- Strong communication and collaboration skills
Education/Experience:
- Bachelor's degree in Engineering (Polymer Science, Mechanical, Chemical, etc) preferred
- 3-5 years of experience in medical tubing extrusion engineering
- Knowledge of extrusion processes and materials
- Experience with designing dies and tooling
- Experience working in a regulated environment (FDA, ISO 13485) is a plus
Key factors for success:
1. Improve processing efficiencies – running to standard then improvement
2. Successful validation hand-offs including training to new processes/equipment
Job Type: Full-time
Pay: $80,000.00 - $90,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Tuition reimbursement
- Vision insurance
Experience level:
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Work setting:
Education:
Experience:
- medical tubing extrusion: 3 years (Required)
- designing dies and tooling: 2 years (Required)
Ability to Relocate:
- Mills River, NC 28759: Relocate before starting work (Required)
Work Location: In person