The company is looking to pioneer breakthroughs in healthcare, specifically in endovascular robotics for neurovascular procedures, aiming to improve outcomes and access to care. The role is to manage the software QA engineering team to ensure the quality of medical device software.
Requirements
- Deep understanding of embedded systems, firmware development, and system software integration.
- Familiarity with regulatory standards and practices for medical software development (IEC 62304).
- Familiarity with cybersecurity standards and data privacy best practices for medical devices.
- Familiarity with scripting, build & test automation tools such as Python, CI/CD pipelines.
- 5+ years of hands-on technical leadership and people management experience of a team of at least 5 software QA engineers.
- Proven experience 15+ years of software verification & validation within medical device product development or highly regulated product preferred.
- 5+ years of working within an Agile SDLC.
Responsibilities
- Develop comprehensive verification plans for embedded and application software for medical devices.
- Manage and Mentor a team of software QA engineers promoting a culture of quality, collaboration, and continuous improvement for verification and validation of medical device software.
- Oversee design of software verification & validation methods, verification test protocols, and test plan reviews to ensure high quality deliverable of medical device software.
- Design and implement both automated and manual test cases for embedded firmware, application software, and integrated systems.
- Ensure all verification and validation activities align with relevant medical device regulations such as ISO13485, IEC62304, and FDA guidelines.
- Collaborate with cross-functional teams including software engineering, systems engineering, quality assurance, product management, and regulatory affairs to ensure successful product development.
- Provide technical guidance and mentorship to the team, fostering a culture of innovation, excellence, and continuous improvement.
Other
- Excellent problem-solving and analytical skills with attention to detail.
- Excellent verbal and written communication skills, documentation, and organization skills.
- Strong leadership skills with experience managing and mentoring.
- B.S. in Computer Science, Computer Engineering, Electrical Engineering, or related discipline; master’s degree preferred.
- Must be able to work with controlled technology in accordance with US export control law.
