System Engineer V&V(Hybrid)

hace 6 días

Tijuana, Baja California, México Insulet Corporation A tiempo completo
Job Title: Systems Engineer V&V

Insulet Corporation is seeking a highly motivated and experienced Systems Engineer to join our team in Acton, MA. As a Systems Engineer V&V, you will be responsible for leading Systems Engineering activities related to verification and validation of Insulet's products.

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 resourced 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 60601-1, 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.
  • Ability to effectively and clearly communicate concepts, ideas, and knowledge to other individuals and teams.
  • Experience in directing associates and leading small cross-functional teams.
  • Familiarity with System Level Testing of software-based Medical Devices is a plus.
  • Previous experience with National Instruments LabView, CVI, Test Stand, and/or Measurement Studio is a big plus.
  • Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes development/verification/validation/procurement/manufacturing/regulatory, and quality experts.
  • Demonstrated skills developing and introducing innovative FDA-regulated medical devices (Class 2 or 3) under Design Controls is a plus.
  • Experience with design and development processes that conform to standards such as ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.

This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days).

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