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Senior Test Lead - Functional Testing

On-site United States

Job Summary

We are seeking a highly experienced and detail-oriented Embedded Software Testing Lead to join our team focused on medical device software. The ideal candidate will have a strong background in embedded systems testing, a deep understanding of medical device regulations and standards, and proven leadership in managing testing teams and strategies.

Key Responsibilities

  • Lead and manage the embedded software testing team for medical device projects.
  • Define and implement test strategies, plans, and procedures for embedded systems.
  • Expertise in all Phases of SW testing Life cycle.

Skill Requirements

  • Ensure compliance with IEC 62304, ISO 14971, ISO 13485, and other relevant medical standards.
  • Collaborate with cross-functional teams including development, systems engineering, and regulatory affairs.
  • Experience in Agile/Scrum methodologies.
  • Exposure to Project planning/Estimation phases
  • Has excellent written and oral communication skills as well as facilitation skills
  • Experience or knowledge of testing complex electro-mechanical system software applications, human-machine interaction systems, or embedded systems is required.
  • Writing and executing test cases ensuring that they meet provided requirements and acceptance criteria
  • Ensuring consistent use of our Quality Management System tools and to document Software Verification Protocols and test results
  • Follow and adhere to the best practices of software test engineering, QA practices and processes in the organization
  • Provide peer review of technical and verification documents
  • Ability to work effectively in a collaborative agile team environment

Other Requirements

  • Experience working within a regulated environment.
  • ISTQB Certification or equivalent.
  • Team and Resource management experience.
  • Exposure to cybersecurity standards for medical devices
  • Experience working with and communicating ideas effectively in a multi-functional team of mechanical, software, and system engineers.
  • Excellent attention to details.
  • Strong hands-on experience working with robots, controllers, vision, safety networks, servo, I/O, integration, and instrumentations.

Source: the employer's careers page. Last checked 2026-10-25. Posted 2026-10-25.

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