Software Validation Job Description
Software Validation Duties & Responsibilities
To write an effective software validation job description, begin by listing detailed duties, responsibilities and expectations. We have included software validation job description templates that you can modify and use.
Sample responsibilities for this position include:
Software Validation Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Software Validation
List any licenses or certifications required by the position: ISTQB, CISCO, AF, ASQ, ISQB, III, IAM, CCC, HQ, ISEB
Education for Software Validation
Typically a job would require a certain level of education.
Employers hiring for the software validation job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Computer Science, Computer Engineering, Engineering, Electrical Engineering, Science, Technical, Software Engineering, Computer, Electronics, Software Development
Skills for Software Validation
Desired skills for software validation include:
Desired experience for software validation includes:
Software Validation Examples
Software Validation Job Description
- Manage risk, produce verification and validation plans, protocols, and reports
- Support change control processes in support of system changes
- Hire, promote, and grow software verification team
- Manage and execute FST/FAT test activities
- Review and approve changes to equipment, process, utilities and methods
- Work directly with marketing and planning team as validation representative to define inputs and requirements to product
- Responsible for design, implementation and modification of new and existing Test Cases
- ParticipatE as validation lead on system debug meetings with external teams
- Responsible for ensuring the accuracy, completeness and compliance of validation deliverables by reviewing the validation packages
- Actively participate in the Validation Life Cycle of regulated projects by developing and driving validation deliverables in accordance with defined procedures, participating in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing and deviation management
- Test automation/scripting, C/C++ programming, Perl
- Master of Science degree in Electrical, Mechanical, or Computer Science Engineering
- Highly self-motivated, work well in a team independently
- Knowledge in web design is a plus
- Working application of FDA cGMP
- Experience with statistics, Statistical Process Control and DOE techniques is a plus
Software Validation Job Description
- Use Canalyzer, Matlab, Simulink, Python and programming languages
- Perform study failure analysis as required
- Collaborate/partner with business analysts on testing options and strategies, including applicable regulatory requirements
- Plan and conduct specification reviews, design assessments, and inspections of assigned software products and requirements
- Design, develop, and implement software validation test strategy, test plans, test automation scripts, and test procedures to meet requirements
- Develop and execute manual and automated scripts for requirement validation, integration, regression, performance and usability testing
- Follow testing strategy and recommend process and work product improvements
- Create test specifications based on product related documentation
- Implement and improve the validation frameworks
- Work closely with engineering team to ensure defects are detected and reported timely
- Requires BS/BA in Engineering, Chemistry, or Life Sciences with 7+ years of related experience within the fields of computers and biotechnology
- Knowledge of software issue management tools such as Serena Business Manager (SBM)
- Experienced in motion control products (Sunroof / Door /Power Liftgate Control Module) or Telematics product is preferred
- Experienced in VT system is preferred
- Experienced in test case management with EA is preferred
- Good English reading/writing and verbal communication skills are required
Software Validation Job Description
- Know EDA SW validation method and process well
- Responsible for synthesis tool evaluation and verification vs 3rd party vendor
- Provides leadership for software development team contributing to the software architecture, design, and implementation of world class, high-performance, intuitive and enterprise grade graphical user interface
- Provides leadership for systems validation team contributing to the test automation, communication protocols validations by ensuring quality and robustness of the products
- Leads the team by playing scrum master role for Agile scrum development projects
- Develop, implement, and verify solutions to assigned problems
- Make presentations of Independent Research & Development (IR&D) material to management and customers for review or promotion of companies’ capabilities
- Provide technical support and assistance for IR&D projects, contracts, or proposal activity in the incumbent’s areas of expertise
- Support other engineers in standardizing Simulink models across different applications
- Automate open loop test cases and carry out closed loop tests
- Experienced in software development and testing on Windows and/or Linux platform (C/C++)
- Experience in the management of regulatory audits
- Prior experience in a managerial capacity, technical experience in a relevant operations function
- Requires a Master's Degree in Computer Science, Electrical Engineering, or a directly related field plus three years of software testing experience
- In lieu of a Master's Degree, employer will also accept a Bachelor's Degree in Computer Science, Electrical Engineering, or a directly related field plus six years of progressive software testing experience
- Experience with at least one automated build framework
Software Validation Job Description
- Develop new test scripts and applications according to specifications and requirements
- Run test suites during major validation cycles
- You will need to have strong experience n validation of audio systems, software development in various scripting languages and C
- An experience in automotive environment will be preferred
- You will need to have very good organization skills and a very structured approach to your work and the ability to have an effective communication with teams located on site and off site
- Drive the testing activities for the ongoing releases – analyze new features, send feedback and add tests if needed, create test plans and reports, execute tests, raise defects, analyze the issues and possible root-causes
- Contributions to the automated solution and continuous maintainance
- Coordinate with the development team and other test teams involved
- Communication & Synchronization with CRE leads – main interface for alignment with customer groups
- Organizes Estimation process in the group for the RFI/RFQ assigned - perform analyses and deliver estimation data
- Understanding to test methodology, test cycle, process is a plus
- We would like someone to join our team who iswilling to learn,has a keen eyes for details, and a good team player
- Experience working with various OSs Windows, Mac, iOS, Android
- Solid experience in Linux SW development/testing-Familiar with OS internals, especially Linux Kernel-Familiar with C programming-Familiar with Shell script-Knowledge/experience on virtualization and its open source implementations will be a good plus
- Computer literacy including word processing, spreadsheet, and databases is essential
- Familiar with basic PC software tools
Software Validation Job Description
- Monitors the key performance indicators (KPIs) and control performance of the group of projects
- Drives efficiency of the group
- Follows up on project audits and actions
- Aligns test activities of the group to the best practices in the domain (Validation CoC) and worldwide
- Provides proper staffing to programs accordingly to resource plans and needed skills
- Supports performance leadership process in the group – responsible for proper establishment and alignment of yearly goals, development plans/training plans, employee career development plans and key roles succession planning of the group
- Design and implement verification and validation environment and test-plans, for the flash memory FW and System, to be used in pre and post silicon platforms including model/simulation, HW/emulation and host
- Take part in integration and feature/product enabling, bring up and debug activities
- Owns Validation signoff for all the products and process
- Responsible for design and development of test cases, test tools, and test scripts for Software
- Develop familiarity in the operation, design, and installation of delivered product expertise in specific functionality
- Basic understanding of global medical device regulations, requirements, and standards preferred
- Prior telecom experience and wireless core network knowledge including but not limited to HLR/HSS, PGW, PCRF/OCS, MME, SGW, SMSC a strong plus
- Bachelor’s degree (BSc) in engineering or Science discipline
- Strong background in FDA, ISO and EU regulations for medical devices and healthcare
- Degree in Software Engineering or Science/Engineering with 3+ years experience in a similar role within the Medical Devices or related Healthcare industry