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.
Required Qualifications:
* 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.
* 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 AgileScrum methodologies.
* Exposure to Project planningEstimation 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
Preferred Qualifications:
* 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, IO, integration, and instrumentations.
