Position Overview

Supports the development and manufacture of medical devices. Will work with Manufacturing and R&D to resolve product quality issues. Supports manufacturing process changes, product design improvements and the implementation of new products. • Supports R&D and quality engineers with design validation and design validation testing of new products • Supports R&D and quality engineers in preparing quality specifications and receiving specifications • Coordinates and assists with first article inspections • Coordinates and supports biocompatibility testing • Manages X-level documentation • Conducts test method validations • Coordinates implementation of new equipment by preparing equipment specifications and by participating in installation qualifications and operational qualifications • Supports the manufacturing of new products • Supports various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal auditing and quality metrics data analysis • Duties as assigned
  • • Knowledge of medical product manufacturing • Ability to understand the technology related to MicroVention’s products • Knowledge of medical product quality assurance • Good mathematics skills • Computer skills including MS Word and Excel, with the ability to learn Statistical Software (MiniTab, Statgraphic, Design of Experiment DOE) • Degree in related field or equivalent • Some related industry experience desirable • Good communication skills