Sr. R&D Sustaining Engineer

Position Summary

We are seeking a Sr. Sustaining Engineer to join our R&D group. This position will play a key role in handling design and process alterations of existing products and managing engineering requirements for distributed products. If you are someone who enjoys gaining technical expertise on a wide variety of new products, all while working across an organization to achieve goals, we would love to hear from you.  This person will have the opportunity to collaborate with teams from various business units.

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
•    Manage and execute engineering requirements for distributed product
•    Coordinate Design Change and Process Change activities 
•    Lead commercialized product change project teams and maintain design history files
•    Assess proposed Design and Process Changes for the impact to the organization; create evidence-based project proposals
•    Prepares project schedules and coordinates engineering activities to ensure outputs meet specifications as well as corporate goals and objectives
•    Develop design inputs and design outputs for changes to existing product or new distributed 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.
•    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
•    Interview, select, train and evaluate performance of new hires
•    Mentor, train and supervise sustaining engineering technicians
•    Ensure company policies and procedures are followed taking timely corrective action with the help of HR when necessary
 

Education / Experience Requirements

•    Bachelor degree or above in a relevant field, or a related scientific/technical discipline 
•    6+ years of relevant experience within the medical device industry
•    Demonstrated project management skills and ability to coordinate multiple projects simultaneously
 

Specialized Skills / Other Requirements

•    Excellent collaborator and communicator of technical concepts to a large audience
•    Ability to work cross functionally and across multiple levels within the organization to support initiatives, obtain stakeholder feedback, and drive critical decisions of projects
•    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
•    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 preferred
 

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