JVT Advisors

Software Design Assurance

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Location: Lawrence, Massachusetts 01843
Employment Type: Contract

Job Description

Contract Length:  6 months

Job Summary:  Support the activities related to the design, development, and ongoing maintenance of software-based medical device products and supporting software.

Responsibilities:

  • Provide quality oversight and guidance for Software Design and Development, for product and non-product software.
  • Review deliverables of the development lifecycle for correctness and compliance to policies.
  • Lead major efforts, or phases of projects, to resolve Software Quality-related problems
  • Lead/support Risk Management activities to ensure software design and process shortcomings are identified and appropriately addressed
  • Support the product development teams in the adoption and use of best practices, Quality tools, and Software Design Control methodologies

Requirements:

  • Bachelor's Degree in Engineering or Computer Science
  • 5+ years related Software Quality Assurance/Quality Engineering experience
  • Working knowledge of FDA Quality System Regulation 21 CFR Part 820, General Principles of Software Validation, IEC62304, and ISO13485 required.
  • Excellent verbal communication and technical writing skills
  • Ability to interface with multiple groups in the organization.

Trevor Hoffman

Technical Recruiter

Trevor recruits for JVT's Life Sciences and Technology Practices where he specializes in finding, screening, and placing top-tier industry innovators at companies across multiple markets and verticals.

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