Senior Test Lead - Functional Testing (US)

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.

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

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.