Arthrex California Technology, Inc.
Engineer Sr I - Electrical Manufacturing (Engineering)
Support the Manufacturing development, implementation and improvements of device testing of components and manufacturing test processes to produce cost effective quality products.
Essential Duties and Responsibilities:
· Leader in development and optimization of test methods for electronic equipment manufacturing.
· Manage and develop the test technicians and electrical test engineers in test methods and troubleshooting, debugging and failure analysis of electronic components and systems.
· Give guidance and provide feedback in the testing and data collection of electrical components, documenting processes for continuous improvement, both internally and with suppliers.
· Responsible to monitor, track and drive electronic yield issues to root cause.
· Develop equipment and processes in support manufacturing capacity ramping
· Develop and write technical reports including work instructions, SOP, MAP and MAT.
· Setup and conduct tests of complete systems and components under operational conditions to investigate system performance, to obtain data for standardization, and quality control.
· Analyze test results in relation to specifications and test objectives and modify or adjust equipment and/or processes to meet specifications.
· Record test procedures and results, numerical and graphical data, and recommendations for changes in product or processes
· Manage tasks related to multiple projects, prioritize and respond to special assigned projects.
· Specify, Evaluate and Coordinate electrical test equipment purchases.
· Support Design Engineering on specific product and process evaluations and engineering studies
· Assist with the design, development, test and manufacture of electrical products and fixtures
· Make sketches and rough layouts, record data, make computations, analyze results, and write reports.
· Use principles and theories of science, engineering, and mathematics to solve technical problems.
· Root cause investigations, analysis and reporting in support of CAPA system.
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:
· Bachelor of Science Degree in Engineering required; preferably Electrical Engineering.
· 7 years of relevant experience required.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
· Strong knowledge of endoscopic visualization systems including optics, mechanical systems, electronic design, analog circuit design, electro-mechanical design, high speed digital circuits.
· Understanding of applicable medical device regulations for electrical safety and EMI/EMC
· Demostratable experience in developing and optimizing QA processes, including Final Test and in processes verification of electronic systems.
· Demonstratable experience in electronics testing and troubleshooting (digital and analog).
· Strong experience in reading electrical schematics, testing and troubleshooting to root cause.
· Documentation of manufacturing procedures, test protocols, test reports and CAPA.
· Knowledgeable of FDA and ISO 13485 guidelines for the development of medical devices.
· Strong communication skills, accountability to project deliverables and budget adherence.
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.