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Grifols Shared Services North America, Inc Senior Verification and Validation Engineer in San Diego, California

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 Engineering (Computer, Electrical, Chemical, etc), Life Sciences or equivalent.

Experience

8+ years of experience in V&V and product development in regulated environment

Equivalency

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.

Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Occupational Demands:

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

Pay Scale :

The estimated pay scale for the Senior Verification and Validation Engineer role based in San Diego, California, is $119,950 to $149,938 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

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Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

Req ID: 513713

Type: Regular Full-Time

Job Category: Research & Development

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