Materials Engineer II

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Location: Irvine, CA US
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We are looking for an experienced Materials Engineer to join our growing enterprise. As the Materials Engineer you will be responsible for optimizing material component’s quality, cost and supply throughout our global operations for consumable and capital equipment. The Materials Engineering Team is responsible for generating favorable purchase price variances (PPV) and cost savings by optimizing supplier performance and by identifying and qualifying alternative suppliers.

We're looking for an individual that can assure and maintain the design integrity and quality of the products; collaborate on product design improvements including cost reductions and reliability improvements, support the Production and Materials teams at our contract manufacturers, and increase customer satisfaction through continuous product and process improvement, complaint analysis, and identification and implementation of innovative approaches to problems. This position will report to Director of Global Supplier Development.

In particular you can expect to: 

  • Work with suppliers and manufacturers to perform failure analysis, resolve component problems, including identifying root cause and permanent solutions when necessary.
  • Compile accurate cost analyses for make vs. buy decisions and proposed supply chain improvements with respect to cost improvement projects.
  • Work with suppliers, supply chain and internal engineering groups to effectively address material obsolescence issues and alternative material opportunities.
  • Lead cross-functional communications with suppliers, operations, finance, quality, purchasing, safety, engineering and other key functions to support maximum output.
  • Evaluate components, subassemblies and full units for performance and work with component suppliers, product engineering, and R&D to adjust dimensional and material specifications to optimize design for manufacturability.
  • Support the QMS systems and standards framework.
  • Generate and execute engineering changes, including document approval, and training.
  • Coordinate and document internal and external process validations.
  • Manage design qualification testing including, biocompatibility, shipping, packaging, aging and sterility testing.
  • Support continued compliance with all regulatory requirements and worldwide regulatory authorities, including CFRs, MDD, ISO, FDA, BSI, TUV and others as we continue to expand product distribution and service.
  • Participate and lead projects to decrease product cost and improve product quality including production transfers and integration activities.
  • Manage multiple material related projects efficiently and effectively. Set and meet competing deadlines
  • Develop assembly/test methods and equipment.
  • Knowledge of statistical methods, Statistical Process Control (SPC) and Design of Experiments (DOE).
  • Perform other work-related duties as assigned.

You will have the opportunity to:

  • Improve patient outcomes.
  • Meaningfully impact the company’s short-term and long-term success.
  • Work closely with executives across the organization.
  • Grow your role as you see fit.
  • Learn everything there is to know about respiratory medical device manufacturing.
  • Create an inspiring workplace.

To be successful, you will need:

  • 5+ years’ relevant professional medical device experience.
  • Demonstrated experience in cost reduction and quality improvement projects.
  • Knowledge of Medical Device Risk Management procedures.
  • Ability to work independently and effectively in a fast-paced environment.
  • Understanding of the properties and behaviors of different raw materials and functionality of basic electro-mechanical components.
  • Respiratory Equipment and Device experience is a plus.
  • Expertise in medical device plastics (PVC, polycarbonate, etc.) and/or electro-mechanical system components (motors, PCBAs, cables, etc.) a plus.
  • Six-sigma certification a plus.
  • Experience in lean manufacturing a plus.

Some logistics:

  • Location: The current office is based in Yorba Linda however we be moving to the Irvine area. Once property is identified in Irvine this position will relocate to the new space based in the Irvine area.
  • Travel: 25 - 40%
  • Physical Demands: May require light physical effort as in periods of prolonged standing, sitting at files or work tables or bending, stooping or reaching and/or occasional lifting of light items (i.e. up to 30 lbs). May require some exposure to chemicals used in manufacturing processes.
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