System Engineer V&VMid-levelHybridFull-time4 months ago

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About the job

The Systems Engineer V&V is a member of the Systems Engineering COE and a technical expert responsible for leading Systems Engineering activities related to verification and validation of the team’s products. Education and work experience should encompass a wide array of engineering disciplines relevant to: mechanical testing, system testing, material testing, 3rd party (agency) testing, shelf life and aging testing, simulated use, and drug-device compatibility testing.

What will you do?

  • Manage all Verification and Validation activities and deliverables for New Product Development and Lifecycle Project Teams.
  • Develop detailed Verification and Validation Plans for assigned projects
  • 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).
  • Collaborate with Systems Engineering in Systems Engineering COE to ensure that all requirements are testable
  • 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
  • Conduct and encourage frequent formal and informal communication with team members to ensure full engagement and efficient operation.
  • Analyze design changes implemented after execution of verification and validation to determine regression testing required
  • Provide technical consulting and mentoring in areas of expertise to early-career members of the Design Verification Test Team
  • 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)
  • Develop new Test Cases and/or update existing Test Cases to match requirement updates and new understanding of system performance
  • 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
  • Perform verification testing following proscribed Test Cases for assigned projects.
  • Other duties within the scope of the Position Overview as assigned
  • Ensure compliance with the team's quality policies, procedures and practices
  • Ensure compliance with all local, state and federal regulations, policies and procures

Qualifications

Minimum Requirements:

  • Bachelors’ 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 judgement with extensive technical leadership skills
  • Demonstrated capability of leading Verification & Validation Test Programs
  • Excellent Program Management Skills – PMP Certification a plus
  • Previous experience working in an Agile based Software Development environment strongly preferred.
  • Familiarity with the story design and the use of Atlassian Tools (JIRA, Confluence, Bamboo) in the software development process.
  • Experience guiding team/individuals to develop technical solutions to complex problems
  • Sound knowledge of engineering first principals
  • 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
  • Good written and verbal communication skills
  • Familiarity with System Level Testing of software based Medical Devices
  • Test Engineering training and/or certification is a plus
  • Previous experience with National Instruments LabView, CVI, Test Stand and/or Measurement Studio is a big plus
  • Creative out-of-the box thinker who can devise new approaches and processes that meet regulatory needs adapt to business and market needs
  • 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
  • Experience with design and development processes that conform to standards such as ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971

Skills

Hard Skills

  • Quality Management
  • Testing

Soft Skills

  • Analytical Thinking
  • Results Oriented
  • Delivery

Technical Skills

  • Jira