Position Summary :
•Provide engineering support to design and/or process alterations to existing products.
•Coordinate Design Change and Process Change activities.
•Develop design inputs and design outputs for changes to existing product or new distributed product.
•Provide R&D support for verification, qualification, and validation studies on existing products.
•Support risk management activities and risk management reviews on existing products.
•Provide R&D support for non-conformance investigations regarding component failures, finished goods failures, and product returns.
•Provide R&D support for customer complaints, including product/record investigation, health risk assessments, identification of CAPA’s, and report generation.
•Support regulatory approvals and responses to regulatory questions for existing products.
Education / Experience Requirements:
•Bachelor’s degree in a relevant field.
•Two years of related experience required.
•Without a technical degree, 5 years of related experience required.
Specialized Skills / Other Requirements :
•Familiarity with various materials and processes, such as extrusion processing, injection molding, machine shop operations, fixtures and tooling, adhesive and thermal bonding and various other processes for catheter fabrication and design required.
•Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications.