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Principal System Verification and Validation Engineer

Company:
Source Consulting/HCL America
Location:
Tucson, AZ
Posted:
June 30, 2020

Description:

Position: Principal System Verification and Validation Engineer

Location: Tucson, AZ

Duration: Contract

ROLE SUMMARY:

Lead the definition, design, and execution of system verification and validation activities (Master V&V Plan) throughout the system development life cycle according to FDA/ISO requirements and Roche quality standards. Hands-on subject matter expert to ensure the completion of V&V activities, including materials for submissions, to meet the project delivery commitments. Responsible for verification of Roche Sequencing platform design and will contribute to the verification of Instrument designs and consumable devices, including unit/sub-system/platform test plan development, execution and reporting

Conceives, plans and conducts advanced independent Systems Development experiments from project inception through product launch and field support, defining project milestones and applying advanced scientific knowledge to complete projects. Designs experiments to test hypothesis related to project outcomes, and analyzes and interprets data/results. Recommends new or creative approaches, and/or expansion or curtailment of investigations based on experimental data or new scientific information arising from area of responsibility. Participates in project planning, process updates, and experimental design. Assumes responsibility for timely completion of projects, ensuring activities are consistent with project critical path and responding appropriately to changing priorities. Ensures technical activities under delegated supervision are concluded within internal and external guidelines and regulations. Interacts with other departments to further project goals.

ESSENTIAL FUNCTIONS:

· Lead the definition, design, and execution of system V&V activities throughout the product development life cycle.

· Development, implements, and maintains V&V strategies, objectives, short- and long-range planning; develops tracking and evaluation programs and project deliverables, and provide update to project teams.

· Creates, reviews and approves V&V deliverables with project team members.

· Ensure the requirements and specifications of the system can be verified and validated, by reviewing use cases, regulatory requirements, risk mitigations and usability.

· Conduct V&V Design Reviews as specified in project plans, and in accordance with Roche procedure.

· Lead ad hoc testing and potential failure mode analysis to characterize product designs and performance.

· 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 and submits to project teams and management for appropriate decision

· Expert knowledge of testing principles and concepts.

· Maintain knowledge of current regulatory requirements and standards as they pertain to the development and testing of medical/IVD 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.

OTHER DUTIES AS ASSIGNED

· Support regulatory team for US and global submissions.

MINIMUM REQUIREMENTS

Education:

· BS in Bachelor degree in Biomedical Engineering, Software Engineering, Electrical Engineering, Life Sciences or a directly related field AND 7+ years of experience in the Medical Device or IVD industry testing new products leading to successful submissions OR Masters/Doctorate degree in Biomedical Engineering, Software Engineering, Electrical Engineering, Life Sciences or a directly related field AND 5+ years of experience in the Medical Device or IVD industry testing new products leading to successful submissions OR advanced technical degree with equivalent work experience with a minimum 12 years of experience with proven technical knowledge and leadership ability

Experience:

· Experience applying quality regulations and standards (e. g. 21CFR 820, ISO 13485, ISO 14971)

· Experience in complying with IVDD (98/79/EC), and IVDR

· Experience in preparing DHF documentation, regulatory submissions, and other technical writing include operating manuals, SOP, IQ/OQ/PQ

· In-depth knowledge of requirement management, risk based testing approaches, defect tracking, and configuration control

· Strong knowledge of statistics for data analysis and calculation of sample sizes

· Experience applying quality regulations and standards (e. g. 21CFR 820, ISO 13485, ISO 14971)

· Experience in complying with IVDD (98/79/EC), and IVDR

· Experience in preparing DHF documentation, regulatory submissions, and other technical writing include operating manuals, SOP, IQ/OQ/PQ

· In-depth knowledge of requirement management, risk based testing approaches, defect tracking, and configuration control

· Strong knowledge of statistics for data analysis and calculation of sample sizes

Thanks and Regards,

Zain Rahman

Technical Recruiter

Source Consulting LLC

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