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.
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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