Test Fixture Engineer I, II, III

Job Title	Test Fixture Engineer I, II, III
FLSA	Salaried Exempt
Department	Research and Development
Reports To	Sr. Engineer, Manager of Engineering, Director of Engineering, Vice President of Engineering, or Chief Technology Officer

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Job Responsibilities:

Complies with Quality System requirements by engaging in appropriate levels GMP/ISO test methodologies, adheres to Quality System Design Control procedures, and applies proper documentation skills.

General Description and Duties:

To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Is 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.
• Oversees 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 on-going accuracy and reliability.
• Analyzes test results, identify potential issues, and provide feedback to design teams for product improvement.
• Diagnoses 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.

Projects and Other Duties:

• Perform other duties as assigned

Position Qualifications

• Demonstrates proficiency in either Mechanical or Electrical engineering according to the engineering position level.
• Ability to adapt and learn quickly leveraging knowledge towards the contribution of projects.
• Ability to use Microsoft Office tools for documentation, analyzing data, presenting data or ideas, etc.
• Ability to use Microsoft Excel and other data analysis tools to manipulate and analyze data sets.
• Ability and experience in using the following test equipment: DVM, oscilloscopes, signal generators, hand tools, such as soldering irons, hand crimpers, screwdrivers, wrenches, and pliers.
• Ability and patience to analyze, debug and troubleshoot electronic circuitry is preferred.
• Competence in data processing or programming skills using Excel VBA, MATLAB, Python, or other similar languages is preferred.
• Competence in the use of CAD software such as Auto cad, SolidWorks, ProE is preferred.
• Competence in the use of Electronics CAD software for schematic capture and PCB layout is preferred.
• Professional, clear verbal and written communications skills required.
• Ability to work independently or in a team setting as required.

Minimum Education:

• BS in Engineering or scientific discipline or equivalent experience.

Minimum Experience:

• 0-5 years’ experience in Engineering based on the engineering position level.
• Experience in designing, maintaining, and qualifying test fixtures for medical devices is preferred.
• Experience in or familiarity with manufacturing processes for medical devices is preferred.
• Engineering with Class II or III medical devices is preferred, though equivalent experience in other regulated environments is acceptable.
• Experience working under regulated quality systems such as cGMP’s, ISO, and the MDR, commensurate with the engineering level.

Salary:

Aligning our overall business objectives with performance and merit based pay, Axonics offers competitive salaries, performance-based incentives, and Employer paid benefits programs to address the diverse individual needs of our employees and their families. At Axonics, our employees come first!
For California, the base pay range for this position is $100,000 to $140,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Axonics is an Equal Opportunity Employer, included protected Veterans and individuals with disabilities.