
Lead Test Engineer
- Alameda, CA
- Permanent
- Full-time
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution
- Tuition reimbursement, the
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
- 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
- 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.
- 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
Alameda : 1360-1380 South Loop RoadADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: NoMEDICAL SURVEILLANCE: NoSIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf