What are the responsibilities and job description for the Principal Embedded V&V Engineer (Medical Device) position at CIS Technologies Inc.?
Hi Associate,
Greetings for the day,
We have a position as a Principal Embedded V&V Engineer (Medical Device) role in Waltham, MA. Please find the job description below for this position.
Role: Principal Embedded V&V Engineer (Medical Device)
Location: Waltham, MA
Duration: 24 Months
Job Description:
- Experience: 10 years of commercial software test engineering experience, with a proven track record in a medical device or scientific instrument environment.
- Deep Embedded Expertise: Extensive, hands-on experience testing deeply embedded systems where software directly controls physical hardware components.
- Regulatory Mastery: Proven commercial experience testing and shipping medical devices under ISO 13485, along with familiarity with current FDA cybersecurity requirements.
- Testing Methodologies: Deep familiarity with feature, regression, and integration testing for complex systems.
- Tooling: Hands-on experience utilizing enterprise Application Lifecycle Management (ALM) systems (such as Azure DevOps) for backlog, sprint board, and test case management.
Nice to Have:
- Previous experience acting as a V&V Manager or Test Lead.
- Bachelor's degree or higher in computer science, engineering, or a related technical discipline.
- Background in developing automated test scripts for hardware-in-the-loop (HIL) environments.
Job Responsibilities:
- Embedded V&V Leadership: Lead the development, review, and execution of software quality assurance processes specifically for embedded medical devices.
- Hardware/Software Integration Testing: Execute manual and automated test cases to verify software that controls hardware as part of an overall scientific instrument system.
- Regulatory Validation: Conduct and oversee software validation activities in strict accordance with FDA regulations and ISO 13485.
- Iterative Process Improvement: Implement tool and process improvements to bring verification test case writing and approval concurrent with iterative Agile development cycles.
- Documentation & Approvals: Review, author, and approve critical software documentation, including validation plans, protocols, summary reports, and cybersecurity risk mitigations.
- Cross-Functional Mentorship: Actively participate in development team ceremonies, review work item acceptance criteria, provide input on estimations, and mentor junior testing staff.
Thanks & Regards
RAJU REDDY |Sr. Team Manager
CIS Technology Inc
Plano, TX 75074
Direct: