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Tooling Engineer CO Open (J#26941)
Education: Bachelors Degree
Experience: 4 - 9 years

Position: Tooling Engineer

CEA Medical Manufacturing

CEA Medical Manufacturing is a contract manufacturer of complex electro-mechanical devices,
specialized cabling, guide wires and catheters used in cardiovascular, gastro-intestinal and
neurosurgical procedures. CEAs 25 year history has been solely dedicated to providing best in class
design and development of medical devices and components to the top 20 global OEM and select
emerging medical device companies. CEAs success is due to the integrity and passion of all of its
employees for providing exceptional service. Therefore, we are committed to providing a culture where
employees are empowered to be successful.

Position Summary:

This position reviews product designs for mold ability and makes recommendations for design
improvements to internal and external design teams. Establishes tooling strategies for device programs
and provides tooling quotes to quoting teams. This positions is also responsible for specifying injection
molds and facilitating all aspects of mold design and fabrication with internal tool shop or external mold
vendors. Facilitates design qualification or factory acceptance testing of injection molds and collaborates
with process engineers to qualify molds for production of medical components. Reviews and improves
mold maintenance programs and procedures as required. Evaluates and troubleshoots production tools
in collaboration with process engineers. May facilitate or support the design, fabrication, and qualification
of de-gating fixtures, assembly fixtures, extrusion tooling, and functional test fixture required in the
manufacturing of medical devices.

Essential Activities and Duties:

Follow all employee guidelines and Quality Systems Regulations (QSR's) as defined by CEA's practices,
policies and Standard Operating Procedures (SOP's) to insure that customer requirements and FDA (or
equivalent) regulations are met.

Follow all employee guidelines and Quality Systems Regulations (QSR's) as defined by CEA's
practices, policies and Standard Operating Procedures (SOP's) to insure that customer requirements
and FDA (or equivalent) regulations are met

Reviews part designs for mold ability and manufacturability and provides feedback to CEA design
engineers and customers

Performs or facilitates Mold Flow analysis and molding simulation to determine gating strategy prior
and during mold design phase; verifies simulation results during design qualification.

Manages timelines for the design, fabrication and design qualification of injection molds and other
tooling or equipment as required.

Manages tooling vendor time lines and provides weekly progress reports to project managers.

Facilitates vendor requirement reviews and mold specifications and acts as vendor liaison for all
molding/tooling related issues

Facilitates design and technical design reviews of injection molds and related assembly,
measurement, and test fixtures as required.

Responsible for quoting injection molds, injection molded parts, and other tooling.

Facilitates the inspection of molds and fixtures, and dispositions discrepancies in collaboration with
CEA design personnel and/or customers.

Facilitates qualification of injection molded components per CEA SOP documents including design
qualification and mold IQ (Installation Qualification). Collaborates with process technicians to perform
process characterization studies on molded parts (DOE), OQ (Operational Qualification) and PQ
(Performance Qualification).

Provides sustaining engineering on production molds and fixtures.

Evaluates and if necessary updates procedures and methods to successfully design, fabricate,
validate, and maintain injection molds, assembly fixtures and other tooling through vendors or within the
CEA development system.


Experience:

B.S. degree in Mechanical Engineering or Plastics Engineering or Industrial Engineering

A minimum of 3 years in a mold making environment

Must be experienced in mold design, mold making practices and mold procedures

Exposure to three-plate mold design, hot runner system, multi-cavities and two shot molding is
desired

Experience in troubleshooting injection molding processes (hands on not required) and choosing /
evaluating inputs and outputs for process characterizations

Familiar with pFMEA, Process Mapping, Design of Experiments, Statistical Process Control and
other six sigma tools

Required Knowledge:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential
functions. Must be able to work in a detail oriented manner within a controlled product development
environment.
 
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