Principal Mechanical Engineer
Designs and develops, and tests all aspects of mechanical components, equipment, and machinery related to the development and manufacturing of an active Class III implantable medical device.
This job will be responsible to develop and verify an advanced, small, precision electro-mechanical device.
Duties and responsibilities
Will be responsible to develop a robust, easily manufactured, reliable, small, precision electro-mechanical device that meets performance specifications.
Applies knowledge of engineering principles to design products such as engines, instruments, controls, robots, machines, etc.
Conducts product testing and creates models and prototypes.
Develops and executes robust systems integration and design outputs testing
Will be involved in fabrication, operation, application, installation, and / or repair of mechanical products.
Works on projects / matters of high complexity.
Works autonomously.
Performs detailed failure analysis on complex, low-occurrence issues that will involve interactions and non-linear factors.
Writes clear assembly and test procedures.
Must know how to write a valid protocol, how to execute a protocol and gather data, how to analyze the results, and how to write a clear and concise report.
Manages, tracks progress, and reports on complex, companywide projects.
The preferred candidate will have experience working within medical device regulations (ISO 13485, ISO 14971, FDA 21 CFR 820) and will have an understanding of how to maintain compliance with the Quality Management System.
Benefits
Salary $160-175K, 401K, and Equity in company.