Arthrex Job - 30660905 | CareerArc
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Company: Arthrex
Location: Santa Barbara, CA
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech


Job Description
Requisition ID:
Engineer II- Automation/Test
Arthrex California Inc
ACI Santa Barbara, CA

Main Objective:

  1. Authors and presents innovative test process and methodology improvements from an end-to-end test perspective for the functional area of ownership.
  2. Participates in ongoing process improvement efforts to ensure test automation is promoted and applied effectively across multiple teams and our supply base.
  3. Align test methods and practices to ensure we have standardized methods and fixtures that are in alignment with our current and future suppliers.
  4. Support manufacturing and service teams by developing and standardizing test methodologies.
  5. Work with operations, developers and technologists to solve, develop and implement new and improved methods for testing production camera systems through automation and vision systems. Perform IQ, OQ and PQ activities for new machines, programs and processes that automate our testing methods.
  6. Define multi-phase validation plans that align with the medical standard validation process for each assigned product. Validation plans include test cases and test scripts, resource requirements, schedule assumptions, and scope that align with the product development.
  7. Creating and documenting test plans, procedures, tools, fixtures and testing software.
  8. Improve current data collection processes from existing testing systems, while making data driven decisions using statistical analysis to improve test yields, reduce cycle times and improve product flow.
  9. The ideal candidate will be a test professional that combines subject matter expertise, industry experience, customer expectation and understanding of product development methodologies to significantly contribute to business results through quality of results, advice and decisions. The ability to formulate validation strategy primarily focused on automation is a primary facet of the role.

Essential Duties and Responsibilities:

  1. Architects test and diagnostic programs, designs test fixtures and test tools, and completes validation specifications and procedures for new and changes to existing products.
  2. Identify develop and design automated testing systems and fixtures for production board level and system level product testing.
  3. Provide guidance and support changes in components and testing processes for production testing.
  4. Analyze test results using statistical methods in relation to specifications and test objectives and develop equipment to simplify the test processes and reduce production test time.
  5. Develop new methods to identify electrical final test while working with Mechanical Engineers to develop equipment and software to support manufacturing capacity, set up and process validations.
  6. Document test plans and instructions, SOP, MAP, MAT, Validation Protocols and Reports.
  7. Proficient in the use of test equipment including, oscilloscopes, wave form monitors, RF test equipment, digital multi-meter, Video Test Equipment, Light Box, Lumens Measurement equipment.
  8. Analyze and develop automated Process Test Yields tracking.
  9. Knowledgeable and experience with using vision system software.
  10. Coordinate test activities with suppliers, develop corrective actions, address line fallout to improve yields, reduce scrap and improve efficiencies.
  11. Data Base Optimization, Data Statistical Analysis and Failure Modes Trending and Tracking.
  12. Present test records / results in numerical and graphical form in order to make data driven decisions.
  13. Manage tasks related to multiple projects, prioritize and respond to special assigned projects.
  14. Responsible for training production personnel.
  15. Perform Failure Analysis, analyze results and document and write reports.
  16. Proficient use and understanding of controls, automation, and electrical troubleshooting.
  17. Use principles and theories of science, engineering, and mathematics to solve technical problems.

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

  • Bachelors of Science Degree required, preferably in Electrical Engineering, Physics, or Computer Science.
  • 3 years of relevant work experience required
  • Work experience with testing camera and optical systems in the medical device industry preferred.

Knowledge and Skill Preferred / Specialized Courses and/or Training:

  1. Preferred experience with software such as CV, Altium, Matlab, LabView, Visual Basic, Python, Java, Lenox, and HP-VEE, as required to develop test systems.
  2. Strong knowledge of developing automated testing solutions for manufacturing of camera systems including optics, electronic design, analog circuit design, electro-mechanical design, high speed digital circuits and servo motors.
  3. Understanding of robotics and software used to control robotics and vision system applications.
  4. Capable of optical system alignment, critical analysis, troubleshooting, testing and characterization.
  5. Good understanding of applicable medical device regulations for electrical safety and EMI/EMC.
  6. Demonstrable experience in developing and optimizing Electrical Test Processes for manufacturing.
  7. Demonstrable experience electronics (digital and analog) trouble shooting.
  8. Solidworks proficiency.
  9. Strong experience in system analysis, testing, troubleshooting to root cause.
  10. Documentation of manufacturing procedures, test protocols, statistical test analysis.
  11. Ability to read and analyze schematics and electrical engineering drawings.
  12. Knowledge of FDA and ISO guidelines for the development of medical devices.
  13. Strong communication skills, accountability to project deliverables including timing and budget requirements.
  14. Knowledgeable of Six Sigma and Statistical Analysis preferred.
  15. Green Belt or Black Belt preferred.
  16. Team player that enjoys working with other engineering disciplines.

Machine, Tools, and/or Equipment Skills:

  • Knowledge of camera equipment and instrumentation, electronic test equipment, PC, Logic Analyzers, Oscilloscopes, Video waveform analyzer, TDR, pneumatics, robotics, Servo Motors.
  • Bench top testing and troubleshooting, cable harness assembly with typical lab equipment.
  • LabView, Matlab, MS Access, SAP, SQL Server, Python, Computer Vision Systems (CV), Microsoft Project/Workfront or other project management tools, Microsoft Office, PCs.
  • Altium schematic capture, PCB layout, Soldering and desoldering skills preferred.
  • Automated Test Equipment, PLC programming, Robotics Systems.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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