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                                                                                                                                                                         

·       4-7 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.

#MEICMSJOBS