Posted:1 day ago|
Platform:
On-site
Full Time
Job Description
The Systems Engineer V&V 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.
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
4yrs to less than 8 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 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.
Horizontal Talent
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