Lead Test Engineer

New Today

The Opportunity
This position is based in our Alameda, CA location within the ADC Division. Our mission is to empower people with diabetes to manage their health through innovative products that deliver precise data for better decision-making. We're transforming glucose monitoring with our cutting-edge sensing technology. Technical specialist with comprehensive knowledge in the area of electrical engineering, manufacturing processes, and/or software development.Helps drive the design and manufacture of continuous glucose monitors and bio wearable sensors and systems. What You’ll Work On •Author test specifications for high-volume manufacturing of continuous glucose monitors and receivers •Reviews and contributes to product acceptance criteria and test limits •Reviews and contributes to process and design FMEAs to ensure manufacturing tests are adequate •Reviews and contributes to test method validation protocols •Specifies and develops test fixtures for PCBA functional test, RF testing and calibration, and audio/display functionality. •Provide technical guidance to external suppliers and third-party manufacturers. •Represent operations and R&D in cross-functional teams •Write and submit Engineering Change Orders into the product life cycle documentation system Required Qualifications B.S. in Engineering Discipline (Electrical or Physics preferred) Relevant experience in electrical engineering and at least 2 years of engineering management experience. Excellent written and verbal communication skills are essential. Excellent knowledge of general Engineering principles. Extensive Knowledge of regulations for medical device development (ISO134851, ISO13485, FDA) is a plus. Extensive understanding of processes and materials used in the development and manufacturing of medical devices, particularly handheld devices. Extensive experience in all of the following: Performing complex engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis Working in a development environment with an emphasis on medical product development. Writing process/product requirements and design specifications. Equipment/facility/process commissioning and validation required Working on a development team with an emphasis on minimizing time to market. Design for manufacture of low cost, high volume handheld electronic products. Extensive knowledge and understanding of GxP, ISO and medical device regulations and the development/implementation of new products/processes in a regulated environment. Extensive experience working in cross functional team environments is required. Strong technical experience in Electrical engineering discipline. Preferred Qualifications 5+ years of experience with electrical testing and test automation with electrical lab equipment 3+ years of experience with high-volume automated manufacturing 2+ years of experience with electronic circuit design or analysis 2+ years of experience managing other engineers Professional experience writing requirements, and validation protocols Experience with root-cause analysis and troubleshooting embedded systems and/or manufacturing processes Able to participate in code reviews and develop software in C#, Python, C++ or a similar language Familiarity with wired and wireless communication protocols, e.g.: UART, SPI, NFC, Bluetooth, WiFi
Location:
Alameda

We found some similar jobs based on your search