Systems Engineer V&V

hace 2 semanas

Tijuana, Baja California, México Insulet Corporation A tiempo completo
Job Title: Systems Engineer V&V (Hybrid) - Innovation Leader

About the Role:

We are seeking a highly motivated and experienced Systems Engineer V&V (Hybrid) to join our expanding team at Insulet Corporation. As a key member of our Systems Engineering COE, you will be responsible for leading Verification and Validation activities related to our medical devices.

Key Responsibilities:

  • Manage all Verification and Validation activities and deliverables for New Product Development and Lifecycle Project Teams.
  • Develop detailed Verification schedules utilizing time-based resource management tools.
  • Perform detailed requirements analysis and manage Test Cases and Test Runs using RQM Tools (DOORs, Helix, Jama).
  • Participate in the planning and execution of technical project work.
  • Create and document novel and robust test methodologies and provide feedback and recommendations for product/design changes.
  • Analyze design changes implemented after execution of verification and validation to determine regression testing required.
  • Manage 3rd party verification activities to ensure product is fully compliant with all applicable standards (i.e., IEC/AAMI/UL, 1-2 and applicable collateral standards).
  • Perform dry-running of new and updated Test Cases.
  • Perform systemic review of Test Cases to ensure that both typical use and edge cases are properly covered (happy-path, alternate path, negative path, etc.).
  • Perform and maintain product configuration management for assigned projects.
  • Ensure compliance with Insulet quality policies, procedures, and practices.
  • Ensure compliance with all local, state, and federal regulations, policies, and procedures.

Requirements:

  • Bachelor's Degree in Biomedical Engineering, Software Engineering, Computer Science, Mechanical, Electrical Engineering, or a related field.
  • Minimum of 3 years' experience testing medical devices in a multidisciplinary project team environment or advanced degree and 1+ years of experience.

Preferred Skills and Competencies:

  • Strong technical judgment with extensive technical leadership skills.
  • Demonstrated capability of leading Verification & Validation Test Programs.
  • Familiarity with the story design and the use of Atlassian Tools (JIRA, Confluence, Bamboo) in the software development process.
  • Sound knowledge of engineering first principles.
  • Strong Analytical and Problem-Solving Skills.

What We Offer:

Insulet Corporation offers a dynamic and innovative work environment, with opportunities for professional growth and development. We are committed to attracting and retaining top talent and offer a competitive compensation package, including a hybrid work arrangement that allows for a balance of remote and on-site work.

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