Career Opportunities: Staff Mechanical Verification Engineer (62055)

We are seeking a Staff Mechanical Engineer to join our Neuromodulation R&D department in the role of Mechanical Verification Engineer. As a Mechanical Verification Engineer you will be responsible for support of sustaining and new product verification, working with a collaborative team with a focus on implantable components. You will write test rationale and test procedures, design and create test fixtures and perform informal development tests as well as formal verification tests. You will work collaboratively with principal level mechanical engineers to implement design improvements to existing products and prove them out. You will also work collaboratively to design test plans and test methodologies for new products. 

YOUR RESPONSIBILITIES 

• Define mechanical verification test rationale in collaboration with product design and clinical teams 

• Execute informal development tests and formal verification tests 

• Define and track detailed test plans 

• Define, architect, design and drive implementation of scalable test infrastructure 

• Define, design and qualify custom test fixtures for informal and formal testing 

• Architect and own a dashboard of test execution completion, issues encountered and resolutions 

• Own execution, interpretation and reporting of mechanical verification results 

• Support FMEA, failure analysis, tolerance analysis, gauge R&R in close collaboration with process, manufacturing and design teams 

• Architect and execute design of experiments (DoE) and associated technical reports 

• Perform statistical analysis on datasets to summarize results and concisely communicate to a management audience 

• Manage external vendors for test fixture development, outsourced test execution and data collection and review vendor test reports and ensure compliance with requirements 

• Stay up-to-update with the regulatory trends and technologies in medical product development (e.g., effect of EU regulation changes) 

• Virtually attend frequent meetings with worldwide team 

REQUIRED QUALIFICATIONS  

• 4+ years of mechanical design or verification in implantable medical device industry or similar high-reliability industry 

• Bachelor’s degree in Mechanical Engineering, BioMedical Engineering or equivalent 

• Experience with definition of verification requirements 

• Experience with mechanical verification and failure mode assessment 

• Solid modeling software experience (e.g. SolidWorks) 

• Experience executing tests on industry standard test equipment (e.g. Instron, thermal chambers, DAQs, etc.) 

• Experience with rapid prototyping techniques (e.g., 3D printing, minor electrical assembly)  

• Experience in the fabrication and rework of mechanical test fixture components using basic machine tools 

• Basic knowledge of statistical analysis (particularly regarding Design of Experiments) and regression analysis (using JMP or similar) 

• Experience working in cross-functional teams and consistently driving projects forward  

• Strong written and oral communication skills for cross-functional and external communication 

• Problem-solving and critical thinking, particularly in root cause investigation 

PREFERRED QUALIFICATIONS 

Candidates with one or more of the following qualifications will be prioritized 

• 7+ years of mechanical verification in implantable medical device industry 

• Master’s degree in Mechanical Engineering, BioMedical Engineering or equivalent  

• Experience working in an ISO 13485 regulated environment 

• Familiarity with biocompatible materials and manufacturing processes in area of implantable leads, insertion needles, anchors and similar accessories, especially in spinal cord stimulators 

• Experience managing electrochemical testing, including direct experience or oversight of consultants performing metal dissolution and biocorrosion studies (e.g. Cyclic Voltammetry - CV, Electrochemical Impedance Spectroscopy - EIS, and Potentiodynamic testing) 

• Familiarity with project management methodologies and tools (e.g. MS Project, SmartSheet) 

• Experience in use of AI for scripting and automation for managing large datasets 

• Knowledge of Finite Element Analysis (FEA) using SolidWorks 

TRAVEL REQUIREMENTS 
Must be able to travel internationally and domestically, less than 10% of the time.