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Johnnie Wells
Validation Engineer
Summary
Highly skilled and experienced Validation Engineer with a strong understanding of medical device regulations and industry best practices. Proven ability to develop and execute comprehensive validation plans, conduct risk assessments, perform functional and performance testing, and create and maintain validation documentation. Experience in collaborating with cross-functional teams and utilizing industry-standard software tools. Committed to ensuring the safety, efficacy, and quality of medical devices.
Education
Bachelor’s Degree in Engineering
November 2015
Skills
- Software Validation
- Hardware Validation
- Test Automation
- Root Cause Analysis
- Risk Assessment
- Requirements Management
Work Experience
Validation Engineer
- Participated in design reviews and provided feedback on design inputs and outputs to ensure testability and manufacturability.
- Collaborated with crossfunctional teams (e.g., engineering, design, manufacturing, quality assurance) to ensure efficient validation processes.
- Utilized industrystandard software tools for validation activities (e.g., JMP, SAS, Minitab).
- Stayed abreast of industry best practices and regulatory updates related to medical device validation.
Validation Engineer
- Developed and executed validation plans for medical devices, ensuring compliance with regulatory standards (e.g., ISO 13485, IEC 62304).
- Conducted risk assessments, hazard analyses, and failure modes and effects analysis (FMEAs) to identify and mitigate potential risks.
- Performed functional, performance, and safety testing on a variety of medical devices, ensuring conformance to specifications.
- Created and maintained validation documentation, including test protocols, test reports, and validation summaries.
Accomplishments
- Successfully validated a complex medical device, reducing product launch time by 25%
- Led a team of engineers in implementing a new validation process, resulting in a 20% increase in efficiency
- Developed and implemented a robust validation strategy for a highrisk medical device, ensuring patient safety and regulatory compliance
- Established and maintained a comprehensive validation program for a largescale manufacturing facility, ensuring product consistency and reliability
- Collaborated with crossfunctional teams to validate complex software systems, ensuring seamless integration and functionality
Awards
- Received the Presidents Award for Outstanding Contributions to Validation Engineering
- Recognized for developing innovative validation techniques that improved product quality by 15%
- Honored with the Team Excellence Award for contributions to the development of a breakthrough validation methodology
- Presented with the Innovation Award for developing a novel validation method that reduced validation time by 30%
Certificates
- Certified Validation Engineer (CVP)
- Certified Test Automation Engineer (CTAE)
- IIST Certified Validation Professional
- ISTQB Certified Tester Foundation Level
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How To Write Resume For Validation Engineer
- Highlight your specific experience in medical device validation.
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Essential Experience Highlights for a Strong Validation Engineer Resume
- Developed and executed validation plans for medical devices, ensuring compliance with regulatory standards (e.g., ISO 13485, IEC 62304).
- Conducted risk assessments, hazard analyses, and failure modes and effects analysis (FMEAs) to identify and mitigate potential risks.
- Performed functional, performance, and safety testing on a variety of medical devices, ensuring conformance to specifications.
- Created and maintained validation documentation, including test protocols, test reports, and validation summaries.
- Participated in design reviews and provided feedback on design inputs and outputs to ensure testability and manufacturability.
Frequently Asked Questions (FAQ’s) For Validation Engineer
What is the role of a Validation Engineer?
Validation Engineers are responsible for ensuring that medical devices meet the requirements of regulatory agencies and industry standards. They develop and execute validation plans, conduct risk assessments, perform testing, and create and maintain validation documentation.
What are the qualifications for a Validation Engineer?
Validation Engineers typically have a Bachelor’s degree in Engineering and experience in medical device development or validation.
What are the skills required for a Validation Engineer?
Validation Engineers should have strong technical skills, as well as experience in regulatory compliance.
What is the salary range for a Validation Engineer?
The salary range for a Validation Engineer can vary depending on experience and location.
What is the job outlook for a Validation Engineer?
The job outlook for Validation Engineers is expected to be good in the coming years.