Principal Test Engineer

Vantive US Healthcare USA•Plymouth, MN

3d•Hybrid

About The Position

As a member of the Acute Therapies Verification and Validation engineering team, you would be responsible for supporting product verification, validation, and compliance test activities on electrical and mechanical medical device components/systems. Your test expertise will be applied to all levels of product development from prototypes components to final system design. This will include planning developing, executing, and validating test methods/creating associated documentation. Interface with/support different groups, e.g., R&D, Project Management, Quality, and manufacturing.

Requirements

Bachelor's or master's degree in engineering.
8+ years of experience in test engineering
Experience with medical device systems and component level V&V testing, plans/procedures/reports, equipment, and test methods
Demonstrated results in both Troubleshooting/resourcefulness; use own expertise/guidance from others to identify/resolve critical issues.
Understanding/application of root cause analysis methods.
Knowledge of electrical/mechanical engineering disciplines with ability to read, understand and analyze electrical schematics/ mechanical drawings
Experience using electrical/mechanical lab equipment. e.g., oscilloscope, DMM, power supply, force/pressure gauge, caliper, thermometer, flow meter and scales
Takes a hands-on approach to electro-mechanical testing, fault diagnosis and isolation
Experience creating detailed, clear, and complete documentation and records
Consistent demonstrated experience collaboratively and effectively leading test team and influencing across disciplines/project teams
Strong ability to prioritize and switch multiple tasks/projects as needed, handle a wide range technical projects and lead sr. engineers on test programs.
Comfortable/effective in a fast-paced environment, where teams share a broad variety of duties
Effectively operate in and facilitate cross-functional teams.
Ability to convince management and stakeholders on technical courses of action with using engineering principles, objective evidence and strong written/verbal communication methods.
Engaged self-starter that takes strong ownership of their work, manages ambiguity, has initiative, and aim to accomplish business and department goals and objectives

Responsibilities

Lead the development of complete electromechanical test solutions including strategies, plans, methods, protocols, and reports for verification of requirements on components and systems.
Lead medium to large teams through the planning and execution of Test Engineering programs. This includes constructing detailed, accurate project schedules, interfacing with project management, design, quality, regulatory, compliance and other R&D groups.
Drive quality into product development through analysis, test, and timely feedback of test results/conclusions/influence to the cross functional teams
Reverse engineer designs, review/analyze requirements and fully understand design features to perform test impact assessments and define the scope of test work
Design test cases to include test methodology, test setups, materials, equipment, procedure, and acceptance criteria based on requirements and standards
Guide teams in the functional testing of mechanical assemblies, electrical circuits, and systems
Engaged point of contact for test to cross-functional team meetings/design reviews
Support hardware and software teams in product development, concept feasibility, pre-compliance, integration and change activities by developing test, collecting, and presenting test data
Lead the design/qualification of hardware and software tools/fixtures used to execute test methods and analyze data
Review, understand and characterize electrical/mechanical designs to lead the develop of test methods and ensure coverage of requirements
Lead medium to large teams through test projects for electromechanical components and systems
Read/understand medical compliance standards and requirements, evaluate risk, and develop test procedures the ensure requirements are met
Lead test execution at third party medical device safety test labs
Using engineering principles and best practices develop and implement feasibility and characterization testing on design concepts and prototypes