Associate Test Development Engineer

Shifamed•Los Gatos, CA

22h•$90,000 - $105,000

About The Position

Our Associate Test Development Engineer will proactively drive innovation and validation in design and development in a collaborative way. This position represents an exciting opportunity to join an innovative and high performing team and influence the design and development in early stages; user testing in later stages; and user training for clinical use. As a key member of our team, you will actively drive design testing with engineering methodologies for validation of device function and useability. This position represents an opportunity to influence the design selection, optimization, validation, and test development and enable patient safety and user satisfaction. This position will also play a role in developing quality management system and ensure QMS compliance adherence.

Requirements

A high school diploma, technical courses, or equivalent industry experience.
7+ years of experience in a test engineering role.
Working and demonstrated knowledgeable about medical device regulations, including FDA QSR, 13485, EU MDR etc.
Excellent communication skills: ability to work both independently and in project team setting
Ability to travel as needed

Nice To Haves

Experience in the medical device industry with electromechanical products and/or interventional cardiology products is a plus.
Demonstrated ability of working with suppliers, including understanding of capabilities, materials, and fabrication processes is desired

Responsibilities

Develop engineering test methods to validate device performance to clinical needs. Test method development will also be used in competitive analysis, user training, and demonstration.
Design fixtures and conduct testing of devices under development.
Analyze and present data from tests to contribute to design decisions.
Drive design controls deliverables, including but not limited to design verification and validation documentation and risk management documentation.
Prepare technical documentation, including directions for use, test methods, protocols, and reports, to support design control activities and regulatory submissions.
Provide guidance on applicable standards and regulations, and enable implementation of those into designs.
Review design control documentation, including but not limited to, requirements, specifications, test methods, protocols and reports
Perform other tasks in support of the Quality Management System and Design Control.
Provide periodic updates regarding project status
Proven experience of test method development, execution, and reporting. This includes statistical techniques and data analysis.
Strong proficiency in mechanical design and instrumentation.