Systems Engineer II

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.

·4-7 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) and 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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