The company is looking to improve the quality and outcomes of neurovascular procedures through robotic-assisted vascular interventions, and needs a Senior Software QA Engineering Manager to lead the verification and validation of their 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.
