Staff Mechanical Verification Engineer
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Job Location:
Oswego, NY - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Micro Systems Engineering Inc. (MSEI) is a pioneer in developing innovative implantable medical technologies that improveand often savethe 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. Were always seeking passionate engineers scientists technicians and professionals to help advance our mission and shape the future of medical technology.
Please join us as:
Staff Mechanical Verification Engineer
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 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 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 informaldevelopment testsand formal verificationtests
Define and track detailed test plans
Define architectdesignand drive implementation of scalable test infrastructure
Definedesignand qualifycustom test fixtures for informal and formal testing
Architect and owna dashboard of test execution completion issuesencounteredand resolutions
Own executioninterpretationand reporting of mechanical verificationresults
Support FMEA failure analysis tolerance analysis gauge R&R in close collaboration with processmanufacturingand design teams
Architect and execute design of experiments (DoE) and associated technical reports
Perform statistical analysis on datasets to summarize results andconciselycommunicate 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 theregulatory trendsand technologies in medical product development(e.g. effect of EU regulation changes)
Virtually attend frequent meetings with worldwide team
REQUIRED QUALIFICATIONS
4 years of mechanicaldesign or verificationin implantable medicaldeviceindustry or similar high-reliability industry
Bachelors degree in Mechanical EngineeringBioMedicalEngineering or equivalent
Experience with definition of verification requirements
Experience with mechanical verification and failure mode assessment
Solid modeling software experience ()
Experience executing tests on industry standard test equipment ( 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 (particularlyregardingDesign 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 medicaldeviceindustry
Masters degree in Mechanical EngineeringBioMedicalEngineering or equivalent
Experience working in an ISO 13485 regulated environment
Familiarity with biocompatible materials and manufacturing processes in area of implantable leads insertion needlesanchorsandsimilaraccessories especially in spinal cord stimulators
Experience managing electrochemical testing including direct experience or oversight of consultants performing metal dissolution and biocorrosion studies ( Voltammetry- CVElectrochemical Impedance Spectroscopy-EIS andPotentiodynamictesting)
Familiarity with project management methodologies and tools ( ProjectSmartSheet)
Experience in use of AI for scripting and automation formanaginglarge datasets
Knowledge of Finite Element Analysis (FEA) using SolidWorks
TRAVEL REQUIREMENTS
Must be able to travel internationally and domestically less than10% of the time.
Micro Systems Engineering Inc. is an equal opportunity accordance with applicable law the company prohibits discrimination based on race color religion creed gender pregnancy or related medical conditions age national origin or ancestry physical or mental disability sexual orientation genetic information uniformed service or any other consideration protected by federal state and local laws. Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee | ||
Required Experience:
Staff IC
About Company
At BIOTRONIK, we are committed to helping people with heart and blood vessel diseases or chronic pain live fulfilling lives.
