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Senior Mechanical Engineer, Disposables - NxStage


Lawrence, Massachusetts

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Job ID 21000F62

Available Openings 1

Position Summary:

Take a key role in developing and improving NxStage’s sterile, single use disposables products. The Disposables 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 therapies. You will be part of a team with responsibility for developing and 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.

Core Responsibilities:

• Design new or modify existing products/components 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.

• 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.

• Recommend design improvements.

• Support plant cost reduction projects.


PHYSICAL DEMANDS AND WORKING CONDITIONS:

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Occasionally lift and/or move up to 50 pounds with assistance.

EDUCATION:

Bachelor’s Degree or advanced degree in Mechanical Engineering or related field.

EXPERIENCE AND REQUIRED SKILLS:

• Strong understanding of medical device development processes.

• Strong diagnostic & problem-solving skills desired, including troubleshooting and root cause analysis

• Able to communicate effectively, both verbally and in writing

• Experience with design of experiments.

• Proficient in Solidworks 3D modeling, standard analysis tools and methodologies, mechanical detailing, geometric tolerance analysis, and documentation.

• Knowledge of rapid prototyping processes preferred.

• Strong statistical background preferred

• Project management / team leadership experience desired

• Working understanding of molding and extrusion processes preferred

• B.S. or equivalent experience in Mechanical, Materials, Industrial, or Plastics Engineering

• 5+ years experience in medical product design and/or sustaining engineering.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.