||Engineer II, Product Development and Sustaining
Take a key role in developing and improving NxStage’s sterile, single use disposables products. The PD&S Engineer is involved in all parts of a product’s life, from feasibility evaluation for new features and products to improving the quality, performance,
and cost of dialysis therapy. You will be part of a team with responsibility for supporting a specific product line. Close collaboration with manufacturing, quality, regulatory, and product management counterparts is key to quickly responding to issues, completing
projects, and launching new products.
• Design or modify products to meet patient needs. Debug and refine designs and develop reliability improvements to existing & new products.
• Act independently with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on recent technical knowledge.
• Plan and execute design verification and design validations based on existing or modified specifications and standards.
• Apply state of the art methods to the creation and modification of NxStage products.
• Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.
• Lead / participate in Risk Management activities including, Fault Tree Analysis, Usability Evaluation, and Failure Mode and Effects Analysis activities to ensure process shortcomings are identified and appropriately addressed
• Manage routine small projects without assistance
• Provide technical support for product engineering, design development, integration, test and evaluation
• Investigate the feasibility of new projects, systems or approaches
• Use problem solving and corrective action projects using techniques such as DMAIC or 8-D and appropriate statistical tools to resolve design problems and address quality improvement opportunities.
• Respond rapidly and flexibly to emerging issues in production, quality, engineering, or supply chain.
• Facilitate collaboration between multiple manufacturing sites and business units.
• Investigate and analyze customer service problems and design improvement suggestions. Recommend design improvements.
• Support plant cost reduction projects.
• Travel (domestic and international) up to 10% is required.
||• B.S. or equivalent experience in Mechanical, Materials, Industrial, or Plastics Engineering
• 2+ years experience in medical product design and/or sustaining engineering
• Intermediate knowledge of CAD and rapid prototyping process
• Working understanding of molding and extrusion processes preferred
• Strong statistical background preferred
• Excellent written and oral communication
• Project management / team leadership experience desired
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