Test Fixture Engineer II

Boston Scientific • Irvine, CA

121d • $72,800 - $138,300

About The Position

The Test Fixture Engineer II is responsible for developing, documenting, maintaining, and implementing test fixtures required to manufacture Axonics Sacral Neuromodulation System products at Boston Scientific efficiently and effectively. Test fixtures play a vital role in the manufacturing process by ensuring that the products are made properly and efficiently. This role will have a substantial impact on the business by supporting the development, improvement, and maintenance of these vital pieces of equipment in the manufacturing process. The Test Fixture Engineer will work within the R D team in the Urology department at Boston Scientific.

Requirements

• BS in Electrical Engineering or a related scientific discipline.
• 2+ years of experience in electrical engineering.
• Experience in designing, maintaining, and qualifying test fixtures, preferably for medical devices.
• Experience working under regulated quality systems such as cGMP's, ISO, and MDR.
• Ability and experience in using the following test equipment: DVM, oscilloscopes, and signal generators.

Nice To Haves

• Competence in the use of Electronics CAD software for schematic capture and PCB layout is preferred.
• Experience in or familiarity of manufacturing processes for medical devices is preferred.
• Engineering experience with Class II or III medical devices is preferred, though equivalent experience in other regulated environments is acceptable.
• Ability and patience to analyze, debug and troubleshoot electronic circuitry is preferred.

Responsibilities

• Responsible for the design of test fixtures, considering factors like reliability, throughput, test coverage, product tolerances, test parameters, and ease of use.
• Creates and maintains design documentation for test fixtures which include design requirements, assembly drawings, and bill of materials.
• Creates and maintains supporting documentation for test fixtures including assembly instructions, operation procedures, calibration procedures, installation and operation test protocols (IOQs), and test reports.
• Oversee the manufacturing of test fixtures, including working with vendors and technicians to ensure accurate construction and documentation.
• Helps in the calibration and maintenance of test fixtures to ensure ongoing accuracy and reliability.
• Analyze test results, identify potential issues, and provide feedback to design teams for product improvement.
• Diagnose and resolve issues with test fixtures during operation.
• Performs risk management activities per company SOPs.
• Actively participates in design reviews of his/her own designs and others' designs.
• Works as part of a project team, or on an individual basis to refine existing specifications, develops process improvements, validation testing and makes yield enhancements and cost reductions.
• Performs systems engineering and component engineering activities.
• Ensures documentation is in accordance with Quality System requirements.
• Assists designing, writing, and performing test protocols, and produces test reports.
• Leads or trains Assemblers and Technicians.

What This Job Offers

• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree