Test Lead - Functional Testing
Job Summary:
We are seeking a highly experienced and detail-oriented Embedded Software Testing engineer with 8-10 yrs of experience to join our team focused on medical device software.
Key Responsibilities:
The ideal candidate will have a strong background in embedded systems testing, a deep understanding of medical device regulations and standards.
Skill Requirements
Expertise in all Phases of SW testing Life cycle. Test Planning, Test case design, Test cases writing, Test case review and test results reviews, Defect Logging, Defect Analysis. Regression testing
Experience in Manual testing – Medical devices
Expertise in system and SW testing
Validate cybersecurity patches, hotfixes, security updates, and operating system updates in regulated medical device environments.
Perform installation qualification, patch deployment verification, regression testing, and compatibility testing.
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.
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.
IT experience a plus especially with Windows 2000
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
Must Have Skill
Functional Testing, Manual Testing
Good to Have Skill
Other Requirements:
Experience working within a regulated environment.
ISTQB Certification or equivalent.
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.