Main functionsDevelop and implement precision extrusion and interventional extrusion processes specifically for medical device tubing to ensure high precision product and compliance with tight medical tolerances and standards.
Key responsibilities:- Develop and implement extrusion processes specifically for medical device precision tubing to ensure high precision and compliance with medical standards. Responsible for all aspects of the polymer extrusion line, including but not limited to; set-up and tear down, equipment maintenance and workflow.
- Execute existing complex processes such as (including but not exclusive to) multi lumen, taper tubing or co-extrusions; Balloon tubing.
- Drive process optimization. Work with production personnel and R&D to ensure high precision extrusion requirements meeting customer specifications and tolerances
- Diagnose and resolve issues related to the extrusion process to minimize downtime and defects. Trouble shoot processing parameters when needed using problem solving methodologies.
- Support, coach and align with all Health and safety company policies.
- Provide extrusions in a timely manner in order to ensure production and development schedules are met.
- Collaborate with external vendors to develop tooling and fixtures that result in producing high precision quality products.
- Manage raw extrusion materials in a way that ensures traceability and prevents contamination.
- Maintain comprehensive records and documentation of all extrusion processes, improvements, and compliance with regulatory requirements. Generate documentation on extrusion runs that is used to control traceability and ensure reproducibility.
- Write and execute process and equipment validations (IQ/OQ/PQ).
- Work with Production development, Engineering, Quality, and Manufacturing Departments during concept, prototyping, and release of new products.
- Follow established procedures in order to maintain a clean and organized environment.
- Responsible for the development and supervision of the Extrusion Department
- Support productivity improvement, reducing unnecessary scrap, down time/set-up time.
- Work as part of a team to ensure products and processes comply with the relevant requirements of the quality management system.
- Support scrap-reduction, cost savings and quality improvement teams, with focus on process and material optimization.
- Provide technical support and training to production staff to ensure adherence to best practices and quality standards.
- Direct the maintenance of equipment to optimum running conditions.
- Other assignments as requested.
Employment and Educational Requirements:- Minimum 5 years' experience of hands-on precision extrusion for medical grade products. Including medical TPE and TPU extrusion experience. You know how to set up equipment and run the product.
- Post-Secondary education in a engineering/technical field or relevant technical experience & skills
- Able to work 1st, 2nd or 3rd shifts
- Ability to execute existing complex processes such as (including but not exclusive to) multi lumen, taper tubing or co-extrusions
- 5 years Extrusion experience in a Medical Device manufacturing environment.
- Experience and understanding of extrusion equipment design
- Extensive knowledge in the extrusion of various polymers. Including medical TPE and TPU extrusion experience. (Pebax, Arnitel, Hytrel, PET, PU, HDPE, LDPE, PBT, Polypropylene, Nylons etc as well as tooling and die design and process parameters.
- Expert understanding the effects that viscosity and velocity have on profiles and multi lumen extrusions and the concepts used in tool design to counteract these effects.
Understanding the effects that residual moisture has on material viscosity and resin degradation in the process.
- Expert understanding of the relationships of the process instrumentation to the observed effects on the process.
- Work as part of a Cross-functional team and independently with excellent personal time management skills, creating a collaborative project environment is essential.
- Able to conform to shifting priorities, demands and timelines through analytical and Problem-solving capabilities. Flexible during times of change.
- Good verbal and written communication skills required.
- Good computer skills including understanding databases, spreadsheets and word processing.
- Ability to read and write English, numeracy abilities, manual dexterity.
