Principal Engineer Npi

Job summary
Draft and manage release of test plansPerform test failure analysisEnsure compliance to ISO13485 standards and FDA regulations
Job seniority: mid-to-senior level
Responsibilities
• Draft and manage release of test plans for design verification and validation of medical devices• Draft and manage release of test plans for process validations of medical devices• Write and revise test requirements• Perform test failure analysis of electromechanical systems• Work with external test suppliers and partners to develop testing methodology• Use statistical data to derive test conclusions• Provide audit support for qualifying external test houses• Provide input to User Requirements and System Requirements Documents• Conduct/support Design/Process FMEA• Transfer Design to Production and document Warehousing and Service & Repair criteria• Ensure compliance to ISO13485 standards, FDA regulations, and Good Manufacturing Practice• Support design for testability efforts and make recommendations on existing designs• Provide technical guidance on standards interpretation and applicability to new products• Coordinate with R&D to optimize design for manufacturing and reliability• Champion problem solving and root-cause analysis efforts• Support products pre and post-market for test plan development and improvement of test methodologies• Collaborate with R&D, Quality, Manufacturing, SMEs, and Regulatory to define appropriate testing of products
Requirements
• Bachelor's Degree in ME or EE or other relevant Engineering discipline required• MBA / Master's in ME or EE or other relevant Engineering discipline preferred• Minimum 12 years' experience in test engineering or testing role in the medical device and/or component industry• Design Control experience including design and process verification and validation• Experience using LabVIEW, including Test Stand• Experience with testing of electro-mechanical and/or electrical systems in a production environment
Key Skills Needed
• Coding in C/C++ (including MS Visual Studio C++ 2010 or newer)• Familiarity with project management methods and tools