Systems Engineer II

1 week ago


Hyderabad, Telangana, India Medtronic Full time

SUMMARY OF POSITION

  • The Systems Engineer II will be a member of the Engineering R&D team working on the development and support of medical devices.
Works closely with other members of the engineering staff to provide technical solutions to engineering problems.

  • ESSENTIAL DUTIES AND RESPONSIBILITIES
  • Work in a multi-disciplinary team developing test methods for a complex, electro-mechanical system
  • Design of Experiments, Measurement system Analysis, Test Method Development, Root Cause Analysis, Capability studies, Fixture Qualification, Statistical process control, 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 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.
M

EXPERIENCE

  • 4+ 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
  • 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.

EDUCATION

Required:

  • B.E or B.Tech in Mechatronics , Mechanical or Electrical.

Preferred:

  • M.E or M.Tech in Mechatronics , Mechanical and Electrical.
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