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"Honesty,
Integrity and Reliability" -- The traits we value most in our
customers,
clients and most importantly – Ourselves
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Mechanical/Plastic
Engineer,
Disposables
Job
Description:
The Mechanical/Plastics Engineer, Disposables role performs engineering
component design, review, logistics, and overall CAD and drawing
configuration management for Class I and Class II medical disposables
products.
Responsibilities:
· Designing and developing new
products with a primary emphasis on plastic parts, Ensuring the
correctness of mechanical and 3D parametric CAD drawings in Solidworks,
Establishment of (GD&T) Geometrics Dimensioning and Tolerancing
and inspection, Working knowledge of plastics materials (thermoplastics
and thermoset) and their properties, Working knowledge of tooling
design for injection molding, Working knowledge of plastic assembly
techniques in a Cleanroom environment, and Knowledge of packaging
design requirements for sterilized products. This role also assures
that the product achieves the FDA expectations including Design
Controls, Device History Files, product V&V and other quality
systems requirements of the FDA 21 CFR – Part 820. This role
must perform as a core team member for product development project
teams in order to introduce new and improved products into production
Qualifications:
Education or Formal Training:
• BS in Mechanical, Industrial, Process, Plastics or
Biomedical Engineering, Engineering Technology or Industrial Design
Degree.
• MS in Engineering or Applied Sciences a plus.
Experience:
• Experience in the development of disposable medical device
design requirements, sterilization methods and its effect on materials
and packaging methods.
• A minimum of 6 years of direct experience in developing
plastic injection molding products with BS or minimum of 4 years with
MS.
• A minimum of 8 years experience in design and manufacture of
medical products is preferred for senior level.
• Demonstrated knowledge in a variety of plastic materials and
their properties.
• Experience in peripheral technologies is required (i.e.
fastener design, electronics enclosures and packaging, machining
processes, etc.)
• Experience working under ISO and FDA requirements preferred
(i.e. GMP and Design Controls).
• Ability to establish and maintain the production capability
(CpK) of an injection molding process using tools such as
“Design of Experiments”, “Statistical
Process Control”, etc.
• Knowledge of product verification and validation techniques
(i.e. thermal conditioning, mechanical cycle testing, drop tests,
etc.).
If
you are interested in this postion, please visit our contact page
here
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3401
Quebec St., Se. 3000 Denver, CO
80207 