Product Development Engineer II - Medical Devices

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Product Development Engineer II - Medical Devices:

Use mechanical engineering knowledge to design and develop innovative medical devices, components/subsystems, or processes in support of company’s strategic plan. Participates in patent applications resulting from research.

Responsibilities of the Product Development Engineer

  • Develop new devices and components. Perform verification and Validation activities.
  • Perform testing on devices and analytical analysis on devices.
  • Maintains all documentation and design history files per establish standards.
  • Develop new processes and perform validations.
  • Utilizes engineering software such as SolidWorks, as required.
  • Develops engineering schedules and projects as assigned.
  • Creates Engineering Technical Reports, memos, Engineering Changes and other documentation as needed.
  • Resolves and/or facilitates the resolution of problems including identifying causes to prevent re-occurrence.
  • Maintains high level of professionalism in attitudes and communication with fellow employees and customers.
  • Maintains a clean and professional office and work area.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, ISO regulations, company policies, and processes.
  • Performs other related duties and responsibilities as assigned.

Requirements of the Product Development Engineer:

  • Bachelor of Science degree in mechanical engineering or related engineering field.
  • Three (3) plus years of product development experience in medical devices.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow up skills, as well as attention to detail.
  • Ability to travel approximately 10% .
  • Ability to maintain regular and predictable attendance.
  • Strong back ground in bio-materials
  • Strong CAD abilities.

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