12 Jul
Manufacturing Engineer - Medical Device - Irvine, CA
California, Irvine , 92602 Irvine USA

Vacancy expired!

Manufacturing Engineer - Irvine, CA - Medical Devices Location: Irvine, CA Duration: 1 year Role Offers: Health, Dental, Vision Benefits & 401K Enrollment Options Overview:

  • Act as a technical liaison to support Sensor Manufacturing.
  • Make improvements of processes, systems or products to enhance performance of the job area.
  • Provide in-depth analysis in nature and often provide recommendations on process improvements.

  • Help with SPC investigation and failure analysis processes that identify and reduce the causes for manufacturing variability.
  • Leverage characterization DOE models to establish optimal process and environmental input set points to improve process stability and capability with respect to sensor in-vitro and in-vivo sensor performance.
  • Partner with New Product Introduction teams to develop and execute calibration, process validation (IQ/OQ/PQ) and Test Method Validation (TMV) protocols/reports that exceed FDA-CFR and ISO 13485 compliance requirements.
Must Have: Minimum Requirements +2 year work experience in Manufacturing on a regulated industry Engineering, Biomedical, or Sciences degree through an accredited university Hiring manager is looking for: Background in medical device/pharmaceutical/aerospace industry Experience in highly regulated manufacturing industry Lean Six Sigma Document control software (i.e. SAP, Agile) Quality software (i.e., Trackwise) SPC tools (i.e., Minitab)

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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