Engineer I, Quality
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:
- Support R&D and Quality Engineers with design validation and design validation testing of new products.
- Support R&D and Quality Engineers in preparing quality specifications and receiving specifications.
- Coordinate and assist with first article inspections.
- Coordinate and support biocompatibility testing.
- Manage X-level documentation.
- Conduct test method validations.
- Coordinate implementation of new equipment by preparing equipment specifications and participating in installation qualifications and operational qualifications.
- Support the manufacturing of new products.
- Support 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.
- Strong written and verbal communication skills.
- Computer skills including MS Word and Excel, with the ability to learn statistical software (e.g., MiniTab, Statgraphics, Design of Experiment DOE, etc.).
- Some related industry experience.
- Strong mathematics skills.
- Knowledge of medical product manufacturing.
- Ability to understand the technology related to MicroVention’s products.
- Knowledge of medical product quality assurance.