Senior Engineer, Medical Devices at Compunnel Inc. in Irvine, California

Posted in Other about 2 hours ago.

Type: full-time





Job Description:

Summary:
  • The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. This engineer would have the ability to read and interpret drawings.

Job Responsibilities:
  • Execute production builds both on live WO and under protocols, as needed.
  • Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
  • Read worker logs, product processing sheets, and specification sheets, to verify that records adhere to quality assurance specifications.
  • Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays.
  • Prepare charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization.
  • Observe worker using equipment to verify that equipment is being operated and maintained according to quality assurance standards.
  • Observe workers operating equipment or performing tasks to determine time involved and fatigue rate using timing devices.
  • Evaluate data and write reports to validate or indicate deviations from existing standards.

Software Skills:
  • Ignite PLM (Team center)
  • Previous experience with computer applications and software such as MS Project and Excel.

Skills:
  • Previous experience working on valves or other cardiovascular medical devices
  • Driven product execution and finalizing builds for market release (and lead these efforts)
  • Skilled in report documentation authoring and release
  • Strong communication skills both verbally and written is REQUIRED, this role will have a lot of touchpoints with onsite labs and other facilities driving production
  • Lead change requests, build coordination, and documentation of class II or III medical devices

Education/Experience:
  • Bachelor's degree in engineering required.
  • 5-7 years experience required.

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