Position Overview

Engineer II, Quality Production Support
The Quality Engineer II supports the development and manufacture of medical devices. He/She will work with Manufacturing and R&D to resolve product quality issues. As well as support manufacturing process changes, product design improvements, and the implementation of new products. Duties include:
  • Works with Manufacturing Engineers to review process changes and resolve product quality issues
  • Works with suppliers to maintain high-quality levels of incoming production materials
  • Conducts quality audits of suppliers
  • Work with R&D Engineers to support implementation of new products by reviewing quality and testing plans
  • As assigned, maintains various Quality Systems such as CAPA, supplier quality, equipment calibration, internal auditing and quality metrics data analysis
Engineer Sr, Quality Production Support
Supports the manufacture of medical devices. Will work with Manufacturing and R&D Engineering teams to support manufacturing process changes, resolve product quality issues, and support the implementation of new products. Job duties:
  • Works with Manufacturing Engineers on process improvement and cost reduction projects.
  • Resolves product quality issues and manages non-conformance investigations and corrective actions.
  • Leads / manages QAR / CAPA projects as assigned.
  • Works with Supplier Quality Manager / Engineers to maintain high quality level of incoming production materials.
  • Supports process validation by developing or reviewing test protocols and reports.
  • Supports equipment qualifications by reviewing equipment specifications, IQ / OQ reports and unscheduled maintenance reports.
  • Supports internal and external audits by participating preparation activities and addressing audits findings.
  • Works with R&D, Manufacturing Engineers, Regulatory, and Supply Chain Planner to support implementation of new products on Production floor.
  • Works with R&D and Manufacturing Engineers to develop and update pFMEA based on non-conformance reports and complaints.
  • Works with Manufacturing Engineers to perform product quality metric data analysis.
  • Leads projects in improving effectiveness and efficiency of assembly inspection activities and cross-functional system-related processes.
  • Performs other duties and responsibilities as assigned.
  • Engineer II, Quality Production Support
    • Degree in related field or equivalent
    • Minimum of 3-5 years of related experience
    • Knowledge of medical product manufacturing
    Engineer Sr, Quality Production Support
    • Bachelor’s degree in Engineering or equivalent.
    • Six (6) or more years of engineering experience in the medical device manufacturing industry.
    Desired Qualifications
    • Ability to understand the technology related to MicroVention’s products.
    • Knowledge of medical product quality assurance (including the requirements for test protocols, test reports, and statistical techniques).
    • Computer skills including MS Word and Excel, with the ability to learn Statistical Software (MiniTab, Statgraphic, Design of Experiment DOE).
    • Good interpersonal and communication (orally and in writing) skills.