Engineer - Electrical Manufacturing

Arthrex Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. The Engineer I – Electrical Manufacturing will provide Electrical Engineering support to ACT Production Operations, Quality Engineering, Supply Chain and Product Design teams to achieve business goals. Develop and optimize electrical device testing methods, automated test equipment, statistical data collection, capacity scaling, failure analysis, and validation.

Support new product commercialization and ensure compliance with ISO 13485, FDA, electrical safety, and EMI/EMC requirements. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

• Develop, optimize, and document test methods for electronic equipment manufacturing, including work instructions, test protocols, and validation reports.
• Mentor test technicians and test engineers in troubleshooting, debugging, and root cause failure analysis.
• Analyze test results in relation to specifications and adjust processes or equipment as needed.
• Perform PCB, sub-assembly, and final device testing and/or troubleshooting including Final Checkout.
• Ability to read programming code and develop testing software (LabVIEW, MATLAB, C/C++, etc) and database tools (SQL, Access), while coordinating test equipment procurement, setup, validation, and capacity scaling.
• Lead yield improvement initiatives using SPC, DOE, capability studies (Gage R&R, MSA, and other statistical analysis tools), and data-driven decision making.
• Collaborate with suppliers and internal teams on test readiness, Failure analysis, CAPA, and continuous improvement.
• Provide production process support on manufacturing technical issues daily.
• Maintain and troubleshoot production equipment and tooling, drive automation to replace manual processes, and partner with Quality Engineering to ensure QMS and ISO 13485 compliance.
• Develop procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data and perform Root Cause / Corrective Actions.
• Support new product development /design transfer by leading process development and validations by participating in DFx, including Design for Manufacturing, Assembly & Test.
• Maintain and troubleshoot production equipment and tooling, track repairs, assess validation impact, and drive automation to replace manual processes where feasible.
• Lead process improvement projects using DOE, Lean A3, Six Sigma DMAIC, and statistical analysis, while supporting new product development and project management for electrical designs through all design phases.
• Support a continuous improvement of culture by utilizing lean principles to enhance quality, operational efficiency and cost.
• Execute validation protocols (IQ, OQ, PQ) for equipment and processes and maintain Master Validation Strategies and Plans for manufacturing and data collection.
• Design and develop tooling, fixtures, and new equipment, including mechanical/electrical systems, specifications, validation, and operator training, coordinate quotes and procurement with suppliers.
• Work with suppliers to determine product specifications and arrange for purchase of equipment, materials, or parts and evaluate products according to specifications and quality standards.
• Perform Gage R&R and Process Capability Statistical Analysis.
• Introduce and support new equipment, products, and processes utilizing industry standard project management tools and techniques.
• Identify opportunities to improve manufacturing efficiency, data collection, and SAP processes; plan workforce utilization and design layouts for optimal workflow using lean techniques.
• Ensure data and documentation are consistently accurate and complete.
• Applies statistical methods to estimate future manufacturing requirements.
• Estimates production times, staffing requirements, and related costs to provide information for management decisions.
• Support Audits as a “Subject Matter Expert”.
• Senior levels may supervise Technicians, Engineers or be an individual contributor.

• Limited use and/or application of basic principles,…