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 Years
Location: Hyderabad (Work From Office) - Hybrid
Responsibilities may include the following and other duties may be assigned
- Work in a multi-disciplinary team developing test methods for a complex, electro-mechanical system
- Test Method Development, Root Cause Analysis, Capability studies, Fixture Qualification, Risk Management & Non-Product software validation
- Validate HW/SW Fixtures and Test Methods
- Write validation protocols and reports based on requirement inputs
- Filing of documentation and drawings for approval
- Responsible 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 plans
- Understanding of IEC62304 Standard is plus.
Principal Working Relationships
- Reports to the Sr. Engineering Manager/Engineering Manager
- Accountable to Project Manager(s) for project-related responsibilities
- Frequent 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 Experience
Experience
- 4 Years to less than 12 years of experience with validation of test methods, hard and software, test fixtures.
Knowledge, Skill, And Ability
- Experience with validation of test methods, hard and software, test fixtures.
- Knowledge of principles and applications of biomechanics, physics, mechatronics, and electrical, mechanical and software development
- Experience 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 Python
- Communicates effectively with cross-functional and multi-site teams.
Qualifications Education
- Required: - 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 skills
- Demonstrate strong knowledge on tools and technologies
- Establish trusting relationship with the team and other stakeholders
- Demonstrate problem solving capabilities.
- Delivery of project commitments
