Senior Systems Verification and Validation Engineer

hace 1 día

Tijuana, Baja California, México Insulet Corporation A tiempo completo

At Insulet Corporation, we are looking for a Senior Systems Verification and Validation Engineer to join our expanding team. This role is a technical expert responsible for leading Systems Engineering activities related to verification and validation of our products.

Job Summary:

The Systems Engineer V&V is a member of the Systems Engineering COE and reports to the Manager Systems Design Verification, Systems Engineering COE, Medical Devices R&D located at Insulet's Headquarters in Acton, MA.

Responsibilities:

  1. Manage all Verification and Validation activities and deliverables for New Product Development and Lifecycle Project Teams.
  2. Develop detailed Verification schedules utilizing time based resourced management tools
  3. Perform detailed requirements analysis and manage Test Cases and Test Runs using RQM Tools (DOORs, Helix, Jama).
  4. Participate in the planning and execution of technical project work.
  5. Create and document novel and robust test methodologies and provide feedback and recommendations for product/design changes
  6. Analyze design changes implemented after execution of verification and validation to determine regression testing required
  7. 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)
  8. Perform dry-running of new and updated Test Cases
  9. 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.)
  10. Perform and maintain product configuration management for assigned projects
  11. Ensure compliance with Insulet quality policies, procedures and practices
  12. Ensure compliance with all local, state and federal regulations, policies and procures

Requirements:

  1. Bachelors' Degree in Biomedical Engineering, Software Engineering, Computer Science, Mechanical, Electrical Engineering or a related field.
  2. 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:

  1. Strong technical judgement with extensive technical leadership skills
  2. Demonstrated capability of leading Verification & Validation Test Programs
  3. Familiarity with the story design and the use of Atlassian Tools (JIRA, Confluence, Bamboo) in the software development process.
  4. Sound knowledge of engineering first principals
  5. Strong Analytical and Problem-Solving Skills
  6. Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams
  7. Experience in directing associates and leading small cross-functional teams
  8. Familiarity with System Level Testing of software based Medical Devices is a plus
  9. Previous experience with National Instruments LabView, CVI, Test Stand and/or Measurement Studio is a big plus
  10. 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
  11. Demonstrated skills developing and introducing innovative FDA-regulated medical devices (Class 2 or 3) under Design Controls is a plus
  12. Experience with design and development processes that conform to standards such as ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971

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