Overview
On Site
Depends on Experience
Contract - W2
Contract - Independent
Contract - 12 Month(s)
Skills
Agile
Collaboration
Continuous Delivery
Continuous Integration
Design Controls
LIMS
Management
Project Management
Regulatory Compliance
Reporting
Software Development
Team Leadership
Technical Writing
Job Details
Job Title : Product Owner
Location : Dallas, TX
Duration : long Term contact
Job Description
Technical Product Owner / Technical Product Manager with LIMS, FDA is responsible for defining and executing LIMS development in accordance with FDA design control for internally and externally developed projects. This position requires expertise in software development processes under FDA design control.
Duties and responsibilities:
Planning and coordinating LIMS development as a part of agile development team.
Collaborating closely with assay development, automation, and operations in order to determine requirements for LIMS development.
Prioritizing features and functionalities for development.
Writing and implementing requirements, specifications and testing plans software features and functionalities as a part of agile development team.
Collaborate with external development partners engaged in co-development of products.
Collaborate with stakeholders to ensure compliance of the solution with internal and external IT security and clinical policies and processes. Collaborate with quality team members across the organization to ensure compliance with FDA design control requirements.
Oversee end-to-end testing and diagnostic test validation activities with the development team.
Lead the technical documentation and plan/execute handover to operations to ensure effective launch and operation of the solution.
Work with project management and report on progress, analyze risks and escalate issues to ensure accurate project management.
Required Work Experience:
Proven experience as a product owner.
Proficiency in modern software development practices and tools (e.g., CI/CD pipelines, version control, testing frameworks).
Experience with software development initiatives developed under FDA design control requirements.
Excellent communication skills to engage with both technical and non-technical stakeholders.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.