The Verification and Validation Engineer plans and executes design verification and stability projects to verify device design requirements. These verification activities support the product development, product reliability, and safety testing. The V&V Engineer develops and validates test methods and protocols based on defined requirements and provides clear concise test reports. Performs data analysis activities including: statistical analysis, data reduction and gage repeatability and reproducibility. Interacts collaboratively with a wide range of disciplines to create innovative products in the challenging and rewarding medical device industry.
Principle Responsibilities: (essential job duties and responsibilities)
- Generate design verification and stability project plans
- Partner with Quality to identify/ explore areas of reliability, risk, and sampling for each assigned project.
- Develop test strategies to determine the best means of providing design verification and reliability.
- Develop stability strategies to determine best means of determining material degradation over time
- Validate test methods using equipment qualification, software validation, DOE, and measurement analysis.
- 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.
- Serve as technical expert, mentor, and peer reviewer for system, device and material test methods.
- Effectively execute and manage design verification and stability projects.
- Coordinate assigned projects resources (technical and equipment) maximizing test throughput efficiency
- Plan time and priorities in an effective manner to achieve all tasks assigned with the objective of assuring data integrity and compliance.
- Leading team through the variety of issues that arise during design verification projects.
- Apply design for reliability (DFR) concepts (DFMECA, FTA, etc) during the product development process to ensure that designs are intrinsically reliable.
- Write test reports that summarize the compilation and analysis of basic reliability data from field studies.
- Analyze test data for conformance to pre-determined acceptance criteria and prepare formal reports and results summaries.
- Facilitates engineering team in failure investigations/ root cause analysis for problems identified during lab testing and field issues.
- Work with lab technicians, both internal and external, to execute and troubleshoot product testing
- Use problem solving skills: 5Ms, 5 Whys, Gage R&R, DOE, etc. to determine root cause.
- Provides technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practical, and consistent with organization objectives. Anticipates problems and recognizes when to deviate from standard practices. Exceptions are usually resolved with the concurrence of a team lead or supervisor.
Skills and Experiences:
- Strong technical writing skills
- Knowledge and experience with electronic medical device test and inspection.
- Working knowledge of Engineering design and test standards (e.g. IEC 60601, ASTM F1980-07, etc.)
- Working knowledge of material strength testing (e.g. tensile, compression, adhesive peel, etc).
- Strong track record of independently analyzing test data and assessing compliance with performance requirements. This includes effective troubleshooting skills to isolate test failures/anomalies and to develop recovery action plans
- Good communication skills to convey complex technical information effectively to internal and customer stakeholders
- Need to clearly articulate design verification and stability process concepts to the business community through written and oral presentations.
- Computer skills sufficient to retrieve, manipulate, analyze, interpret, and present data.
- Be part of the solution – to maintain compliance and help manage design verification & packaging testing projects
- Understand regualtory requirements for electronic medical device and product stability to lead project team through technical challenges
- Bachelors of Science in Engineering
- Five or more years engineering experience in medical device (or other regulated industry)
- Knowledge of FDA design control requirements
- Project management experience interfacing with multiple departments
- Demonstrate ability to condense complex requirements into specific and measureable test objectives.
- Proficiency with MS Office business software – Word, Excel, Project, Visio
- Strong technical writing skills
- Project management experience
- MS in engineering
- Knowledge of international medical device standards
- Experience with solid modeling and engineering drawing creation (SolidWorks preferred).
- Strong risk management skills
- Knowledgeable of statistical software, preferably MiniTab.
- Experience in any of the following test categories: thermal, vibration, HALT, electrical safety (EG/ UL/IEC standards particularly IEC 60601).