We are seeking a highly skilled and experienced Principal Systems Test Engineer to join our team. This is a key technical leadership role with the responsibility of leading the development and execution of comprehensive testing strategies for BMT products. You will be responsible for evaluation, development, and implementation of test systems/tools/equipment, including design documentation. The position will provide Verification and Validation expertise to new product introduction of electro-mechanical, software controlled medical devices. This role requires a deep understanding of medical device systems, strong leadership abilities, and a passion for ensuring product quality and compliance with regulatory standards.
Primary Duties & Responsibilities:
- Lead the planning, design, and execution of system-level testing for medical devices, ensuring compliance with regulatory requirements (e.g., FDA, ISO), customer and business needs.
- Develop and implement test plans, protocols, and procedures to verify and validate product functionality, performance, and reliability.
- Analyze and interpret test data, identify issues, and drive root cause analysis and resolution.
- Provide leadership and execution of best test method practices as part of a project team.
- Collaborate with cross-functional team members to ensure alignment on testing objectives and deliverables.
- Design clean, easy to use test fixtures and user interfaces for test equipment that measures robustness of design, provide error-checking, collects data and gives user feedback for acceptance and/or failure.
- Create and maintain traceability of test cases to requirements.
- Support regulatory submissions and audits by providing technical expertise and documentation.
- Use critical thinking and technical knowledge to solve complex system interaction problems.
- Perform work in adherence to the Bracco Medical Technologies (BMT) Quality Management System (QMS), including development and maintenance of documentation.
- Commit to fostering and driving an environment and work output based on continuous improvement.