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Product Development Engineer in Biotech
Develop manufacturing processes which produce a device that meets the User Needs and Design Specifications.
Develop and validate test methods which address the User Needs and Design Specifications of the PHP device with input from the product development team.
Identify, evaluate, install and qualify moderately complex process and test equipment.
Designs moderately complex tools/ fixtures required to assist in manufacturing and testing.
Writes Procedures, Protocol, and Reports.
Works with product development team to evaluate device performance and test methods robustness. Participates in failure analysis /corrective action activities and recommends device modification.
Participates in cross functional activities (i.e. risk analysis, supplier development, CAPA).
Contributes to the creation of intellectual property.
Minimum Bachelors Degree in Mechanical, Biomedical, or Material Engineering plus 3-5 years of engineering experience (or equivalent combination of education and experience).
Minimum 1 year of Experience in Product Development or Manufacturing of Medical Devices
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