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Process Engineer CO Open (J#26942)
Education: Bachelors Degree
Experience: 1 - 3 years

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:
Develop and qualify processes and equipment for injection molding of components and insert molding of
assemblies. Provide guidance to Engineering, Manufacturing, R&D and Quality groups on requirements
for efficient production of molded components. Take on role of resident expert for all molding
processes.

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.

Provide DFM feedback to in-house and outside resources for design changes or updates to provide
long term process stability and robustness.

Work with molding tool designers to identify key features of components and tooling.

Perform inspection and initial functional tests on fabricated mold tooling.

Use knowledge of Scientific Molding Principles to create and execute tooling and component
qualification plans, protocols and trials.

Fully develop processes for new components. Process development to include initial process
settings (IQ), Process Characterization and DOE, challenge of process widow developed (OQ) and
verification of process stability (PQ).

Provide documentation and statistical analysis of results from IQ, DOE, OQ and PQ activities
complied into overall Qualification Completion Report.

Develop process documentation and train production operators.

Specify, evaluate and implement new molding and ancillary equipment. Including specification,
evaluation and implementation of updates to existing equipment to enhance overall company molding
capabilities.

Identify, develop and implement updates to existing processes to reduce scrap and improve
process efficiencies.
Experience:

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

1 to 5 Years of Experience

Required Knowledge:

Scientific Molding Principles as it applies to Injection and Insert Molding.

Processing of wide range of engineering resins including TPR, TPE, PEEK, PC, ABS and Glass
Filled Materials

Qualification requirements for components such as PPAP or qualification of components for medical
use.
 
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