||Mechanical Engineer II
Take a key role in developing and improving NxStage’s equipment. The Mechanical 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 the ME functional team supporting multiple platforms including new development and sustaining activities. 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 Engineering
• 2+ years experience in medical product design and/or sustaining engineering or experience working in a regulated industry.
• Intermediate knowledge of Solidworks and rapid prototyping process
• Functional understanding of GD&T
• Working understanding of designing for multiple manufacturing processes (machining, injection molding,etc.)
• Strong statistical background preferred
• Excellent written and oral communication
• Project management / team leadership experience desired
||Send This Job to a Friend