Precision Extrusion Engineer

Creative Solutions Services, LLC; Taunton (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC in Taunton, MA, is seeking a Precision Extrusion Engineer to develop and optimize extrusion processes for medical device tubing. This full-time, onsite role demands hands-on expertise with high-precision polymer extrusion and strict regulatory compliance.

You'll collaborate with R&D, production, quality, and manufacturing to implement complex processes (multi lumen, taper tubing, co-extrusion), validate equipment (IQ/OQ/PQ), manage materials, and drive process

Qualifications

• 5+ years of hands-on precision extrusion experience in medical device manufacturing.
• Post-secondary engineering/technical education.
• Ability to work 1st, 2nd or 3rd shifts.
• Experience with complex extrusion processes (multi lumen, taper tubing, co-extrusions).
• Knowledge of extrusion tooling and medical polymers (TPE/TPU).

Responsibilities

• Develop and implement extrusion processes for medical device tubing.
• Set up/tear down, equipment maintenance, and workflow management for the extrusion line.
• Execute complex processes: multi lumen, taper tubing, co-extrusions, balloon tubing.
• Drive process optimization to meet specs and tolerances.
• Troubleshoot processing parameters to minimize downtime and defects.
• Support health and safety policies and regulatory compliance.
• Collaborate with vendors to develop tooling/fixtures for high-precision products.
• Maintain traceability and control of raw extrusion materials.
• Write IQ/OQ/PQ validations and keep comprehensive process records.
• Work with Production, Engineering, Quality, and Manufacturing during concept, prototyping, and release.
• Maintain a clean, organized work environment.
• Lead and supervise the Extrusion Department.
• Support scrap reduction, cost savings, and quality improvement initiatives.
• Provide training to production staff on best practices and standards.
• Direct equipment maintenance to optimal running conditions.

Skills

Extrusion

Medical device manufacturing

Problem solving

Quality systems

Documentation

Team collaboration

Education

Engineering degree

Tools

Equipment design knowledge

Job description

Precision Extrusion Engineer

Full-Time

Onsite in Taunton, MA

Main functions

Develop 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 formedical device precision tubingto 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.

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