Principal Sustaining Engineer

PUB362711

工作内容: Principal Sustaining Engineer

Introduction

Our client is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. Their portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care.

  • 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
  • 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
  • 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.
  • Lead 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
  • Interview, select, train and evaluate 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

职位要求

  • Bachelor’s degree in a relevant field.
  • Eight years of relevant experience required.
  • 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 multiple 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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  • 必要的证书
  • 背景调查
  • 自荐信
  • 简历
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PUB362711

Account manager

Max Schumacher
Brunel USA - Minneapolis
m.schumacher@brunel.net

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