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Design Engineer TX Open (J#27215)
Education: Bachelors Degree
Experience: 4 - 9 years

Principal Biomedical Design Engineer:

Primary responsibilities include the design and development of new products. This involves creating designs, modeling and drafting on a 3D CAD system, prototyping, testing, validation and project management of the large scale projects.

Main Responsibilities:
Independently responsible for the design, development of new products and processes by applying engineering and clinical knowledge.
Responsible for deploying expert skills in the use of 3D CAD modeling software, for the purpose of tolerance analysis, fluid flow modeling, structural integrity and mold flow analysis.
In project management-responsible for establishing and executing project timelines.
Manages trains and directs the activities of engineering personnel, may have technicians reporting directly.
Responsible for the application of injection molding, machining processes, systems integration and design of tooling/fixturing required for design concepts utilized for new product development.
Responsible for geometric tolerance and dimension analysis using CAD and, if necessary, hand calculations.
Responsible for generating comprehensive protocols for analyzing, verifying, and validating new products. Will conduct theoretical and statistical analysis for Medivators Medical products.
Generates design assurance documentation for the projects.
Works concurrently with the molding group regarding component design, in order to facilitate optimum design for manufacturing and so as to prevent customer issues.
Responsible for patent research and application for new product intellectual property.
Will lead and/or participate in research and development programs that could involve multiple interfaces internal and external to the company.
Provides engineering support to regulatory, manufacturing, quality control, marketing and sales as necessary.
Assists in Technical File documentation and leads the Design Review process.
Understands and applies Quality System Requirements.
Will interface with manufacturing to apply Lean Manufacturing techniques.
Leads risk and hazard analysis of products.
Applies knowledge of Medical Device Manufacturing requirements for compliance with applicable regulating bodies.
Responsible for translation of customer input into designs and subsequent product specifications.
Performs on site assessment of medical device use and surgical procedures as required.
Assists in the identification, evaluation and implementation of new suppliers into the Medivators system.
Performs or reviews overseas validation/verification testing for design.

Bachelors degree in engineering required. MS preferred in Biomedical, Mechanical or Electrical engineering discipline.
Minimum of 7 years experience in product or process design and development, or 5 years in medical device engineering is required.
Management of technical personnel or program management strongly desired.
Prefer 4 years experience in medical device development.
Prefer molded component experience.
Prefer PMP certification.

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