Senior Verification and Validation Engineer

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary

Grifols Diagnostics Solutions is seeking a Senior Verification and Validation (V&V) Engineer. This position is located in Rancho Bernardo - San Diego, CA and will be reporting to the Manager of Verification and Validation.

The Senior Verification and Validation (V&V) Engineer will lead the definition, design, and execution of product verification and validation activities throughout the product development life cycle according to FDA/ISO requirements and internal quality standards. This individual will be a hands-on subject matter expert to ensure the completion of V&V activities, including materials for submissions, to meet the project delivery commitments. You will be working in a cross functional team alongside Systems Engineering, Project Management, Marketing, Customer Support, Quality, and Regulatory Affairs. In order to be successful in this position we are focused on individuals with at least 8 years of direct hands-on V&V instrument systems experience, leading V&V activities, and solid knowledge in ISO 13485.

Primary Responsibilities for Role

• Work closely with Systems Engineering, Project Management, Marketing, Customer Support, Quality and Regulatory personnel to complete V&V projects.
• Lead the definition, design, and execution of product V&V activities throughout the product development life cycle.
• Serve as V&V representative or Test Lead in the project team or product change control task.
• Implement project V&V strategies by defining and delivering V&V project deliverables.
• Work with project teams to create, review, and approve V&V deliverables. Manage timeline and provide updates to project teams.
• Strong interpersonal skills with the ability to collaborate with others in a multi-disciplinary team or setting, influence decision making, and build group consensus.
• Review use cases, requirements, and specifications for products to ensure that requirements and specifications can be verified and validated. The review also includes risk mitigations, usability, and regulatory requirements.
• Execute complex testing, perform in-depth statistical analysis, and interpret results independently. Ensure that testing and results are traced to requirements; activities are completed with objective evidence. Summarize results in reports with conclusions or recommendations.
• As a hands-on subject matter expert, lead ad hoc testing and potential failure mode analysis to characterize product designs and performance.
• Lead the development and validation of fixtures, software tools, test methods for product design testing.
• Conduct V&V Design Reviews as specified in project plans, and in accordance with company procedure.
• Support regulatory team for US and global submissions.
• Support quality compliance team for complaint handling include troubleshooting and testing.  
• Maintain knowledge of current regulatory requirements and standards as they pertain to the development and testing of medical devices.
• Provide coaching to other V&V engineers for designing test strategies and test cases with strong knowledge of statistics, the calculation of sample sizes and/or estimation of statistical power.

Knowledge, Skills, and Abilities

• Solid understanding of FDA Quality System Regulation, Medical Device Directive, ISO 13485.
• Track record of leading V&V projects for regulated products
• In-depth knowledge of requirements management, risk based testing approaches, defect tracking, and configuration control
• Experience in preparing DHF documentation, regulatory submissions, and other technical writing include operating manuals, SOP, IQ/OQ/PQ
• Strong knowledge of statistics for data analysis and calculation of sample sizes
• Understand good engineering practices and test methodologies
• Excellent oral, written, analytical, computer and interpersonal skills
• Manage multiple projects simultaneously and adapt to changes in program priorities
• Background and hands on experience of immunoassay, PCR, sequencing or other molecular technology is a plus

Education

Minimum requirement: Bachelor’s degree in a technical discipline such as Engineeri