Job description
Turn complex mechanical designs into proven, reliable implantable medical devices that patients can trust. In this role, you will join our Neuromodulation R&D team as a Staff Mechanical Verification Engineer, where you will play a critical role in verifying both sustaining and next-generation implantable products. You will own mechanical verification activities from test rationale through execution and reporting, working hands-on with implantable components in a highly collaborative, cross-functional environment. You will design and execute informal development tests and formal verification testing, create custom test fixtures, and develop scalable test infrastructure to support growing product needs. Partnering closely with principal-level mechanical engineers, you will help drive design improvements, validate solutions, and shape verification strategies for new products from the ground up. This role gives you the opportunity to combine deep technical rigor with real-world impact, ensuring that innovative neuromodulation therapies meet the highest standards of safety, reliability, and performance before reaching patients.
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 profile
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.
Company description
About Us
Micro Systems Engineering, Inc. (MSEI) is a pioneer in developing innovative implantable medical technologies that improve-and often save-the lives of millions living with cardiovascular conditions and chronic neurologic pain. With over 45 years of expertise in designing and manufacturing active implantable devices, our success is built on a foundation of core values: innovation, quality, reliability, integrity, teamwork, and deep technical excellence. These principles drive our global reputation for trust and confidence among physicians and patients alike. We're always seeking passionate engineers, scientists, technicians, and professionals to help advance our mission and shape the future of medical technology.
What we offer
You will design and execute informal development tests and formal verification testing, create custom test fixtures, and develop scalable test infrastructure to support growing product needs. Partnering closely with principal-level mechanical engineers, you will help drive design improvements, validate solutions, and shape verification strategies for new products from the ground up. This role gives you the opportunity to combine deep technical rigor with real-world impact, ensuring that innovative neuromodulation therapies meet the highest standards of safety, reliability, and performance before reaching patients.
