Sr. Engineer V&V

Vantive US Healthcare USA•Plymouth, MN

2d•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 degree in engineering or related field and 5+ years of experience in test engineering
Experience with medical device systems and 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.
Takes a hands-on approach to electro-mechanical testing, fault diagnosis and isolation
Experience creating detailed, clear, and complete documentation and records
Demonstrated experience collaboratively and effectively across disciplines/project teams
Ability to prioritize multiple tasks and coordinate follow engineers/technicians on assigned work.
Comfortable/effective in a fast-paced environment, where small teams share a broad variety of duties
Engaged self-starter that takes ownership of their work, manages ambiguity, has initiative, and aims to accomplish team and department goals and objectives

Nice To Haves

Advanced Molding and Extrusion techniques (Learning / Doing (1))
Automation, reliability & smart manufacturing (Learning / Doing (1))
Critical Systems (Learning / Doing (1))
Data Analysis & Analytics (Applying / Overseeing (2))
Digitalization & Systems Engineering (Learning / Doing (1))
First Principles Thinking (Applying / Overseeing (2))
Instrumentation (Leading / Driving (4))
Lean & six sigma process knowledge (Applying / Overseeing (2))
Machine Learning & Artificial Intelligence (Not Applicable (0))
Manufacturing & Process Knowledge (Applying / Overseeing (2))
Manufacturing Process Knowledge (Managing / Facilitating (3))
Modeling & Simulation (Leading / Driving (4))
Operational Quality Assurance (Learning / Doing (1))
Process Automation (Applying / Overseeing (2))
Product / Project Management (Applying / Overseeing (2))
Product Knowledge (Managing / Facilitating (3))
Quality Management Systems (Managing / Facilitating (3))
Regulatory Compliance (Leading / Driving (4))
Smart Operations / Industry 4.0 (Learning / Doing (1))
Software Integration (API, Data Pipelines) (Not Applicable (0))
Software Process Management (Leading / Driving (4))
Sterilization methods (Leading / Driving (4))
Systems Validation (Leading / Driving (4))

Responsibilities

Own and develop complete electromechanical test plans, methods, protocols, and reports for verification of requirements on components and systems
Lead a team through the planning and execution of Test V&V projects. This includes constructing detailed, accurate project schedules, interfacing with project management, design, quality, regulatory and other R&D groups.
Drive quality into product development through analysis, test, and timely feedback of test results/conclusions 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
Functional testing of mechanical assemblies, electrical circuits, and systems
Contribute 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 tests, collecting, and presenting test data
Design/qualify hardware and software tools/fixtures used to execute test methods and analyze data
Review and understand designs, requirements and traceability to develop test methods, assessments and ensure coverage of requirements
Develop and implement feasibility and characterization testing on design concepts and prototypes