Sr Mechatronics Verification and Validation Engineer

The Senior Mechatronics V&V Engineer will be part of the R&D organization and an important contributor to the realization of the next generation robotic platform that will change the future of healthcare. You will be a visible technical resource working on development & testing of a complex electro-mechanical system. There will be direct contribution from prototype to verification builds and testing within a regulated medical device development environment. This role is suited for a senior-level R&D engineer with experience working cross functionally to plan V&V activities, perform fixture qualification and test method validation, perform V&V tests, perform statistical analysis, author and review documentations, and support R&D development activities.

Key Responsibilities:  

• Leads the system, subsystem verification activities through completion for a complex electromechanical system 
• Develops test plans, verification, and validation protocols, and identify levels of resources, in terms of personnel, budget, schedule, and facilities, to accommodate various test efforts including analysis, inspection, demonstration, and test 
• Develops or refines existing electromechanical fixtures and testers as needed using the mechanical tools (such as SolidWorks) and software (e.g., MATLAB, Simulink, LabVIEW) 
• Develops test methods, protocols, execute tests, prepare reports and release them via ECOs  
• Maintains disciplined test, configuration control, documentation, and management processes throughout 
• Proposes refinements to requirements, and/or test methods, to expedite V&V activities  
• Supports establishment of traceability matrices for all levels of requirements 
• Performs hands-on and simulated testing for design verification and test method developments 
• Analyzes test results. Apply statistical analysis as needed  
• Identifies and reports out-of-specification results, data, and atypical/unexpected events that occur during tests  
• Manages issues, provides technical troubleshooting for hardware testing and support defect resolution through root cause analysis (RCA) and corrective measures to prevent recurrence 
• Performs fixture qualification and test method validation 
• Communicates information clearly, effectively, and frequently (oral and written) with stakeholders, project team 
• Manages and delivers assigned projects in collaboration with cross-functional teams within agreed delivery timelines 

Qualifications:  

• Minimum of 7 years’ electromechanical R&D engineering experience, preferably in the medical device industry required. Some years of experience in other heavily regulated industries will be considered. 
• Bachelor’s and/or Master’s degree in Mechanical, Mechatronics, Robotics Engineering or a close field is required 
• Proven proficiency in developing test methods, protocols, performing tests and releasing relevant documentation is required. 
• Experienced in fixture and process validation. 
• Experienced in using statistical tools and software such as Minitab, MATLAB 
• Must have experience in cross-functional collaboration and technical leadership 
• Must have hands-on experience in assembly, integration, and test of complex electro-mechanical systems 
• Must have MATLAB/Simulink proficiency. LabVIEW proficiency is desired. 
• Demonstratable CAD proficiency a plus. Solidworks preferred 
• Demonstrable proficiency in statistical data analysis methods / tools, e.g.: Gage R&R, Hypothesis Testing, Tolerance Interval Analysis, Acceptance Sampling, etc. 
• Must have working knowledge of applicable medical device regulatory standards i.e.: FDA 21CFR 820, ISO 13485, IEC 60601, ISO 14971, etc. 
• Must have experience in project management including task timeline estimation and work breakdown structures 
• Outstanding documentation and communication skills required  
• Proficiency in using MS Office required