Test Fixture Engineer Research and Development Irvine, CA

Axonics Modulation Technologies; Irvine (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

An established industry player is seeking a talented engineer to design and maintain test fixtures for medical devices. This role involves collaborating with cross-functional teams to ensure compliance with quality standards while utilizing various engineering tools and methodologies. The ideal candidate will possess strong mechanical or electrical engineering skills, along with proficiency in data analysis and documentation. Join a forward-thinking company that prioritizes employee well-being and offers competitive salaries, performance incentives, and a supportive work environment. If you are passionate about engineering and eager to make a difference in the medical field, this opportunity is perfect for you.

Benefits

Performance-based incentives

Employer-paid benefits programs

Competitive salaries

Qualifications

• Proficiency in Mechanical or Electrical engineering is essential.
• Experience in designing and qualifying test fixtures for medical devices is preferred.

Responsibilities

• Design and maintain test fixtures while ensuring quality and compliance.
• Analyze test results and provide feedback for product improvement.

Skills

Mechanical Engineering

Electrical Engineering

Data Analysis

Troubleshooting

Communication Skills

Education

BS in Engineering

Equivalent Experience

Tools

Microsoft Office

Microsoft Excel

DVM

Oscilloscopes

Signal Generators

CAD Software

Electronics CAD Software

Job description

Reports To Sr. Engineer, Manager of Engineering, Director of Engineering, Vice President of Engineering, or Chief Technology Officer

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 ongoing accuracy and reliability.
• Analyzes test results, identifies potential issues, and provides feedback to design teams for product improvement.
• Diagnoses and resolves 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, develop process improvements, validation testing and make 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 AutoCAD, 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.
• BS in Engineering or scientific discipline or equivalent 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 cGMPs, ISO, and the MDR, commensurate with the engineering level.

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, including protected Veterans and individuals with disabilities.

Questions?

We are here to help answer any questions you may have about Axonics Therapy.