Sustaining Engineer II

Position Summary

We are seeking a Sustaining Engineer II to join our Mechanical R&D group. This growth position will play a key role in handling design and process alterations of existing products.This position is responsible for products with a wide range of clinical applications. This person will have the opportunity to collaborate with teams from two of our R&D sites namely, Tecate-MEX and Maple Grove-MN.

Principal Responsibilities

•    Provide engineering support to design and/or process alterations to existing products
•    Manage engineering activity required to support products through the commercialized life cycle
•    Coordinate Design Change and Process Change activities 
•    Assess proposed Design and Process Changes for the impact to the organization; create evidence based project proposals
•    Develop design inputs and design outputs for changes to existing product
•    Develop new test methods and/or alter existing test methods
•    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.
•    Support commercialized product change project teams and maintain design history files
•    Ensure design change and process change activities, processes and practices are in compliance with internal quality system requirements.
•    Maintain and supplement design history files that are thorough and accurate for existing product
•    Ensure company policies and procedures are followed taking timely corrective action with the help of HR when necessary
 

Education / Experience Requirements

•    Bachelor’s degree in a relevant field.
•    Two years of relevant experience required.
•    Must be bilingual (English/Spanish)
 

Specialized Skills / Other Requirements

•    Must possess knowledge, understanding and skills in: product designs/concepts, catheter materials, project management, documentation, and a working knowledge of quality systems and medical device regulations.
•    Excellent collaborator and communicator of technical concepts to a large audience.
•    Ability to work cross functionally and across muliple levels within the organization to support initiatives, obtain stakeholder feedback, and drive critical decisions of projects.
•    Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications preferred.
•    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.  

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