Principal Sustaining Engineer

Position Summary

We are seeking a Principal Sustaining Engineer to join our Mechanical R&D group. This growth position will play a key role in handling design and process alterations of existing products and managing engineering requirements for distributed 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, Chelmsford-MA and Maple Grove-MN.

Principal Responsibilities

•    Execute and lead sustaining engineering activities required to support products through the commercialized life cycle
•    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 or new distributed product
•    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
•    Prepares project schedules and coordinates engineering activities to ensure outputs meet specifications as well as corporate goals and objectives
•    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
•    Support regulatory approvals and responses to regulatory questions for existing products.
•    Lead commercialized product change project teams and maintain design history files
•    Ensure that design change and process change activities, processes, and practices comply with internal quality system requirements.
•    Maintain and supplement design history files that are thorough and accurate for an existing product
•    Identifies and leads continuous improvement activities
•    Interview, select, train, and evaluate the performance of new hires
•    Mentor and train Sustaining Engineers
•    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.
•    Eight years of relevant design experience required.
 

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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