Our client, a fortune 100 international manufacturing giant, seeks a candidate for their medical diagnostic devices division.
If interested, please forward resume with salary requirements, relocation and visa status.
Requirements:
Capture and Document Software User Requirements and technical Software Specifications.
Serve as a liaison between internal customers such as Marketing, Service and Support, and the Software Development Team to capture customer requirements and transpose them into functional software specifications.
Verify that all Requirement activities are in compliance with Requirements Multi Site Work Instructions, FDA, and ISO 9000 regulations.
Verification:
Determine methodology for testing of modules and/or sub systems.
Exercise independent judgement to adapt and modify standard testing techniques.
Development of software test procedures and test plans. (manual or automated).
Execute test cases, and document results.
Participate, where appropriate, as a reviewer in specification and design reviews.
Leadership:
Ability to work independently and track all work activities to schedule to ensure timeliness of deliverables.
Demonstrate the ability to negotiate and influence stakeholders during the requirements capturing process.
Introduce new methods, tools, and processes within department function.
Remain current in area of expertise and provide functional expertise across projects.
Skills:
Software Requirements and/or Verification position for a minimum of 3 years.
Working knowledge of at least one defect tracking system.
May have knowledge of Computer Assisted Software techniques and programs (i.e.: Quick Test Pro or Winrunner).
Knowledge of Requirements Management Tools such as DOORS.
Must have working of FDA guidelines for the overall software development process and especially software requirements and verification.
Knowledge of ADVIA Chemistry Product Line a plus.
Education Disciplines:
Bachelors Degree in Computer Science, Medical Technology, or related field.
Level of Experience: 5 to 8 years.
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