Job Title - Senior Verification & Validation Engineer
Location – San Diego, CA
Duration – 6+ Months Contract
Total Hours/week - 40.00
1st Shift
Description:
Sr. Eng, Design Validation
* 510K Critical need
The Senior Verification & Validation Engineer is responsible to plan, conduct, and report on design verification and validation testing within the R&D group of a medical device manufacturer. This position will be responsible for the development and qualification of test protocols based on design verification requirements. Will perform data reduction and preliminary statistical analysis and provide engineering support for engineers across a broad range of disciplines in the challenging and rewarding medical device industry.
RESPONSIBILITIES:
• Function as design verification lead on assigned project teams with accountability for the development, execution, and reporting of verification activities. As well as system validation testing to meet the user need.
• Work with assigned project team(s) to ensure that testability is a consideration during the development of engineering requirements.
• Assist with the product development teams to formulate 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.
• Co-ordinate assigned project resources (technicians and equipment) with the objective of assuring data integrity and maximizing test throughput efficiency.
• Develop 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.
• Assist engineering team with root cause analysis for problems identified during verification testing.
• Work with manufacturing and service teams to develop tests for use in confirming the continued conformance of products.
• Support manager in identification and acquisition of equipment to enhance lab capability and capacity.
• Mentor other Verification Engineers and technicians.
EDUCATIONAL REQUIREMENTS:
• Bachelor’s or Master’s Degree in Mechanical Engineering, Electrical Engineering, or other Engineering
RELATED EXPERIENCE REQUIREMENTS:
• 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
systems Verification / validation exp within a medical device or regulated field. prefer local candidates, phone, skype interview.