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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
Developstestplans, verification, and validationprotocols, andidentifylevels of resources, in terms of personnel, budget, schedule, and facilities, to accommodate various test efforts including analysis, inspection, demonstration, and test
Developsor refines existing electromechanical fixtures and testers as needed using the mechanical tools (such asSolidWorks) and software (e.g.,MATLAB, Simulink, LabVIEW)
Developstest methods, protocols, execute tests, preparereportsand release them via ECOs
Maintainsdisciplined test, configuration control, documentation, and management processes throughout
Proposesrefinements torequirements,and/ortestmethods,toexpediteV&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
Analyzestest results. Apply statistical analysis as needed
Identifiesand reports out-of-specification results, data, and atypical/unexpected events that occur during tests
Manages issues, providestechnical troubleshooting for hardware testing andsupportdefect resolution through root cause analysis (RCA) and corrective measures to prevent recurrence
Performsfixture qualification and test method validation
Communicatesinformation clearly, effectively, andfrequently(oral and written) with stakeholders, project team
Managesanddeliversassigned projects in collaboration with cross-functional teamswithin agreed delivery timelines
Qualifications
Minimum of7years’ electromechanical R&D engineering experience, preferably in the medical device industryrequired Some years of experience in other heavily regulated industries will be considered.
Bachelor’s and/orMaster’s degree inMechanical,Mechatronics,RoboticsEngineering or a close field isrequired
Provenproficiencyin developing test methods, protocols, performingtestsand releasing relevant documentationisrequired
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 inassembly, integration,and test ofcomplexelectro-mechanical systems
Must have MATLAB/Simulinkproficiency LabVIEWproficiencyis desired.
DemonstratableCADproficiencya plusSolidworkspreferred
Demonstrableproficiencyin 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 skillsrequired
Proficiencyin using MS Officerequired
Who we are We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
To find out more about Siemens Healthineers businesses, please visit our company page here
The base pay range for this position is:
$114,920 - $158,015
Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.
If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.
Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.
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Siemens Healthineers is a leading medtech company with over 125 years of experience. We pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our portfolio, spanning in vitro and in vivo diagnostics to image-guided therapy and cancer care, is crucial for clinical decision-making and treatment pathways.
With our strengths in patient twinning, precision therapy, as well as digital, data, and artificial intelligence (AI), we are well positioned to take on the greatest challenges in healthcare. We will continue to build on these strengths to help overcome the world’s most threatening diseases, enable efficient operations, and expand access to care.
We are a team of more than 71,000 Healthineers in over 70 countries passionately pushing the boundaries of what is possible in healthcare to help improve the lives of people around the world.