Systems Engineer V&V

11 hours ago

Hyderabad, Telangana, India Horizontal Integration Full time ₹ 6,00,000 - ₹ 18,00,000 per year

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

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