Validation Engineer
3 days ago
The Systems Engineer V&V (Medical Device) will collaborate closely with cross-functional engineering teams and focuses on supporting the execution of test cases and test strategies, ensuring the high performance and reliability of products in Surgical Robotics.Experience: 4-12 YearsLocation: Hyderabad (Work From Office) - HybridResponsibilities may include the following and other duties may be assignedWork in a multi-disciplinary team developing test methods for a complex, electro-mechanical systemTest Method Development, Root Cause Analysis, Capability studies, Fixture Qualification, Risk Management & Non-Product software validationValidate HW/SW Fixtures and Test MethodsWrite validation protocols and reports based on requirement inputsFiling of documentation and drawings for approvalResponsible for the end-to-end process involved in demonstrating the System meets our product requirements.Participate in the documentation, communication, and review of undesirable test outcomes, and/or design enhancements, and determine impact of changes to test plansUnderstanding of IEC62304 Standard is plus.Principal Working RelationshipsReports to the Sr. Engineering Manager/Engineering ManagerAccountable to Project Manager(s) for project-related responsibilitiesFrequent interaction with team members from other disciplines, particularly hardware engineers, to develop project requirements and other project artifacts such as project schedules. Possible interaction with clinicians, third-party vendors, manufacturers, subcontractors and other users.Required Knowledge and ExperienceExperience4 Years to less than 12 years of experience with validation of test methods, hard and software, test fixtures.Knowledge, Skill, And AbilityExperience with validation of test methods, hard and software, test fixtures.Knowledge of principles and applications of biomechanics, physics, mechatronics, and electrical, mechanical and software developmentExperience writing technical reports for the medical device industry and should be able to work on small CDPs.Solid understanding of Design Controls, Medical Device Design Verification, and GDP (Good Documentation Practices)Experience in Minitab, MATLAB or LabVIEW and PythonCommunicates effectively with cross-functional and multi-site teams.Qualifications EducationRequired: - B.E or B. Tech in Mechatronics or Electrical or Mechanical (second priority)Preferred: - M.E or M. Tech in Mechatronics, Mechanical and Electrical.Demonstrate strong System Verification & Validation skillsDemonstrate strong knowledge on tools and technologiesEstablish trusting relationship with the team and other stakeholdersDemonstrate problem solving capabilities.Delivery of project commitments
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