Software Quality Engineer - Enterprise Platform & Solutions


Milpitas, CA

Industry: IT Consulting/Services


5 - 7 years

Posted 295 days ago

  by    Pratap jiandani

This job is no longer available.

Job Title Software Quality Engineer

Relevant Experience 

(in Yrs) 6+ years

Technical/Functional Skills

? Deep understanding of FDA Guidance Document on software validation, IEC 62304 and ISO13485

? Must have a minimum of 3years of Software Quality Assurance experience in medical device industry  

? ASQ Certification as a Quality Engineer is preferred


?Experiencerequired in software quality assurance in medical device industry

Roles & Responsibilities

?Responsible to develop Software Quality Plan. This includes standards to be used (coding and documentation standards), review and audit plan, configuration management plan, etc.

? Must develop Software Requirements Specification (e.g. functional requirements, performance requirements, safety requirements, design constraints, etc.)

? Must perform Risk Analysis (FMEA, FMECA, FTA)

? Must be able to develop Software Validation Plan (SVP)

? Must be able to develop develop Software Architectural Design (architecture diagrams, data flow diagrams, etc.)

?Responsible for developing Software Design Specification (SDS), traceability analysis from SDS to SRS and SVP to SDS/SRS

? Able to run Unit/Module Test and Write Test Report, Run Integration Tests and write Test Reports, Run System Tests and write Test Reports

? Writing relevant procedures such as Software installation procedure

? Review and update any necessary documents (e.g., SRS, Risk Analysis, SDS, SVP, Test Protocol and Report, etc.)

? Provide overall guidance to the project team on software development planning, Verification & Validation (V&V) including black box testing, software lifecycle processes and methodologies, configuration management, with emphasis on quality assurance and testing best practices in accordance to FDA Guidance and ISO Standard 62304 and 13485

? Develop quality documentation for software Risk Management, review and approve software requirements, review and approve software V&V test protocol and reports 

? Develop software testing methodologies for production and complaints that are software related

? Develop test methods for verification and validation of algorithms

? Develop and utilize simulations and models

Generic Managerial Skills

? Must have strong organizational, analytical and problem-solving skills

? Ability to produce time management skills during execution

? Ability to work in a team proactively, flexibly in an environment


?Bachelordegree in engineering or relevant field