Support the development and manufacture of medical devices. Work with Manufacturing and R&D to resolve product quality issues.
Support manufacturing process changes, product design improvements, and the implementation of new products. Job duties :
Work with Manufacturing Engineers to review process changes and resolve product quality issues.
Work with suppliers to maintain high quality levels of incoming production materials.
Conduct quality audits of suppliers.
Work with R&D Engineers to support implementation of new products by reviewing quality and testing plans.
Work with R&D and Manufacturing Engineers to develop the DFMEA and PFMEA.
Work with R&D and Manufacturing Engineers to develop test protocols and reports (design verification, design validation, process qualification, and process validation).
As assigned, maintain various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal auditing, and quality metrics data analysis.
Perform additional duties and responsibilities as assigned.
Bachelor’s degree in Engineering or related field.
Minimum of two (2) years of related experience.
Strong written and verbal communication skills.
Proficient computer skills including MS Word, Excel, and statistical software (e.g., MiniTab, Statgraphics, Design of Experiment DOE, etc.).
Knowledge of medical product manufacturing.
Strong mathematics skills.
Ability to understand the technology related to MicroVention’s products.
Knowledge of medical product quality assurance (including the requirements for test protocols and statistical techniques).