Extrusion Engineer

Job Description

GENERAL:

This position is responsible for the design, development, production and optimization of extrusion processes for the company’s medical device components, including the engineering needs of operations and equipment setup.

ESSENTIAL FUNCTIONS:

1. Develops and optimizes extrusion processes to meet design specifications and performance criteria.

2. Provides engineering support on extrusion equipment and tooling to support internal manufacturing, quality and sales operations.

3. Leads the setup, calibration and operation of equipment; optimizes extrusion parameters to improve product quality and manufacturing efficiency.

4. Designs and develops new tooling and equipment.

5. Designs, develops and implements cost saving initiatives on the production floor.

6. Conducts process validation and qualification activities; evaluates and analyzes results. Develops testing procedures, specifications, and supporting documentation.

7. Maintains documentation on the research and development process through lab notebooks or other methods.

8. Specifies and orders components and tooling.

9. Determines safety limits of equipment and sets appropriate stops. Ensures compliance with all relevant industry standards and applicable safety requirements.

10. Performs experiments to determine the validity of designs.

11. Implements and maintains process control systems to ensure repeatability and adherence to tight tolerances.

12. Collaborates with R&D and product development teams. Assist in statistical analysis and supports new product development, including material selection and prototypes.

13. Installs and operates extrusion equipment.

14. Troubleshoot and result extrusion process issues, identifying root causes and implementing corrective actions to minimize downtime and scrap.

15. Investigates equipment or process problems, devises methods of repair, and makes adjustments or directs related efforts of others.

16. Tests, troubleshoots, repairs, and validates equipment, using LEAN MANUFACTURING concepts.

17. Develops quantitative parameters for quality inspection and testing as required per customer and regulatory quality requirements, manages calibration and maintenance of all equipment.

18. Stays current with advancements in extrusion technology and materials relevant to the company.

ADDITIONAL FUNCTIONS:

1. Supervises technicians and operators

2. Participates in PTEE Ram Extrusion.

3. Attends and participates in a variety of meetings and task force groups to integrate activities, communicate issues, obtain approvals, resolve problems and maintain high level of knowledge pertaining to new developments, requirements, and policies.

MINIMUM QUALIFICATIONS:

· Bachelor’s degree in mechanical engineering, materials science or related field, or equivalent work experience

· A minimum of 2 years’ experience in Medical Extrusion.

· Ability to read and create technical drawings.

· Experience with a wide variety of polymers (PJC, PU, PE)

· Experience with two or more of the following: single/multi-lumens, profile, co-ex, vacuum, taper, over coating and substrate extrusion processes.

· In depth knowledge of cGMP, FDA and ISO 13485 regulations

· Tooling design experience a plus; candidates with 2 years minimum CAD experience will also be considered.

· Understanding of basic engineering principles with strong mechanical aptitude.

· Ability to communicate well through written and verbal means.

· Strong knowledge of Microsoft Office, Solidworks and basic statistical knowledge.