Senior Verification & Validation Engineer

Responsibilities

• Function as design verification lead on assigned project teams with accountability for the development, execution, and reporting of verification activities.
• Work with assigned project team(s) to ensure that testability is a consideration during the development of engineering requirements.
• Absorb responsibility for the formulation of test strategies during development testing.
• Create and execute comprehensive design verification and validation test plans including sample sizes for assigned projects.
• Partner with Quality and Reliability Engineers to determine need for reliability tests. Work with manager to develop and execute reliability test plans.
• Coordinate assigned project resources (technicians and equipment) with the objective of assuring data integrity and maximizing test throughput efficiency.
• Create and qualify new test protocols, ensuring that test objectives are effectively incorporated. Design and coordinate the fabrication of unique test fixtures required for protocol execution.
• Proactively identify potential issues with measurement systems; create and execute gauge repeatability and reproducibility (GR&R) studies to assess measurement system effectiveness.
• Apply basic quality engineering statistics to help the project team in making fact-based decisions (D.O.E., hypothesis testing, etc.). Train others in using statistical techniques.
• Create custom control, user interface, and data collection programs using LabView.
• Work with lab technicians to assemble, test, and troubleshoot mechanical, electronic, electromechanical, and pneumatic test setups and data acquisition systems.
• Analyze data from verification and reliability test for conformance to pre-determined acceptance criteria and prepare formal reports and results summaries.
• Absorb responsibility for the assistance of engineering team with root cause analysis for problems identified during verification testing.
• Support manager in identification and acquisition of equipment to enhance lab capability and capacity.
• Mentor other Verification Engineers and technicians.

Qualifications

• Bachelor’s or Master’s Degree in Mechanical Engineering, Electrical Engineering, or other Engineering
• 9-12 years experience in electromechanical system testing and/or design
• Working knowledge of analog and digital electronics. Ability to troubleshoot, improvise, and work from schematics
• Knowledge of test control and data acquisition systems (LabView experience preferred)
• Basic working knowledge of engineering/quality statistics
• Demonstrated ability to condense complex requirements into specific and measurable test objectives
• Basic working knowledge of MS Project, MS Excel, MS Word
• Ability to communicate effectively, both verbally and in writing.
• Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment.
• Minimum three years’ experience within a regulated industry.
• Experience in planning and conducting Gauge R&R studies.
• Knowledge of reliability prediction methods/data analysis
• Working knowledge of Minitab
• Experience in any of the following test categories: thermal, vibration, HALT, electrical safety (e.g. UL/IEC particularly IEC 60601), EMC, package testing
• Knowledge of medical device processes in the following areas: Sterilization, Validation, Biocompatibility Testing, Package Validation, and Software Verification