KOSMOS
Extrusion Engineer
KOSMOS, Daytona Beach, Florida, United States, 32118
Growing Manufacturing firm near Daytona Beach, Florida has a need for an Extrustion Engineer. This is a direct hire role with a full benefits package.
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.
QUALIFICATIONS AND EXPERIENCE:
· Bachelor’s degree in mechanical engineering, materials science or related field, or equivalent work experience
· A minimum of 2 years’ experience in 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.
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.
QUALIFICATIONS AND EXPERIENCE:
· Bachelor’s degree in mechanical engineering, materials science or related field, or equivalent work experience
· A minimum of 2 years’ experience in 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.