Verification and validation Engineer_______________San Antonio, TX

"Verification" and validation and ("Medical device")
Full Time, Full Time
Depends On Experience
Telecommuting not available Travel not required

Job Description

Verification and validation Engineer

 

San Antonio, TX

 

Fulltime

 

 

Technical/Functional Skills

  • 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.

 

Experience Required

  • Knowledge of FDA design control requirements
  • 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

 

Roles & 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.

 

Regards,

Mohit Yadav

D-248-565-4747*148

Posted By

Pawan Upadhyay

Dice Id : 10335759
Position Id : 273082
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