Lead Test Engineer

Abbott Laboratories; Alameda (CA); On-site; USD 128,000 - 256,000; Full time

Job summary

Abbott Laboratories is seeking a Technical Specialist in Alameda, CA, focusing on the design and manufacture of innovative glucose monitoring devices. This position involves authoring test specifications, collaborating with external partners, and ensuring compliance with engineering and regulatory standards. The right candidate will have a B.S. in Engineering and extensive experience in electrical engineering and project management, especially within the medical device sector.

Benefits

Free medical coverage

Excellent retirement savings plan

Tuition reimbursement program

Qualifications

• B.S. in Electrical Engineering or Physics preferred.
• 2+ years of engineering management experience required.
• Excellent knowledge of medical device regulations, particularly for handheld devices.

Responsibilities

• Author test specifications and validate test methods for glucose monitors.
• Provide technical guidance to external suppliers and manufacturers.
• Participate in cross-functional teams and write Engineering Change Orders.

Skills

Electrical Engineering

Communication

ISO Regulations

Project Management

Statistical Analysis

Problem Solving

Education

B.S. in Engineering Discipline

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• 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.

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

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is $128,000.00 – $256,000.00. In specific locations, the pay range may vary from the range posted.