Senior Systems Engineer

Define and execute test strategies for system-level, integration, and hardware-level testing. Understand the end-to-end verification process which ultimately demonstrates the system meets all requirements. Develop and maintain comprehensive V&V documentation, including but not limited to verification plans, verification protocols and reports, test method validations, traceability matrices, and risk assessments. Provide regular updates and communicate progress, findings, and recommendations to cross-functional teams, stakeholders, and management. Drive continuous improvement initiatives to enhance the efficiency and effectiveness of the verification and validation process. Establish alternative verification approaches, including inspection, verification via trace, design review, analysis, simulation, and or automated testing strategies which minimize manual testing effort while maintaining regulatory and quality compliance. Develop a deep understanding of product function, requirements, and design intent to assess the impact of changes and issues, shape test strategy, and build effective V&V plans. Investigate unexpected results using structured problem-solving methods. Look beyond the immediate failure to identify root causes, contributing factors, and implications for product quality. Drive defects from identification through investigation, resolution, and verification, working across disciplines to turn findings into effective solutions. Communicate findings and recommendations clearly, using evidence to help the team prioritize issues, and make informed decisions. Anticipate obstacles, unblock work, and find creative ways to meet challenging schedules while preserving the rigor and quality of V&V evidence.

Hands-on experience planning, developing, executing, and documenting verification or validation tests for complex products, with the ability to connect requirements and risks to objective evidence. Demonstrated systems thinking, structured problem solving, and sound judgment when requirements, interfaces, or test results are ambiguous; ability to work across disciplines to reach a documented path forward. Working knowledge of applied statistics and experimental design, including the ability to choose an appropriate analysis, justify a sampling approach, and explain what test data does and does not establish. Experience with complex, electro-mechanical, software-controlled systems, particularly medical devices developed under the rigor of a quality system. Product development experience working in an Agile/iterative environment utilizing continuous integration. Experience with requirements and test-management systems such as DOORS, OpenText ALM, Jama Connect, Polarion, or Codebeamer used to create, review, and trace all product development content. Ability to analyze data with Minitab, R, Python, MATLAB, or similar tools and communicate findings in clear technical reports or dashboards. Ability to develop dashboards and product performance reports leveraging Monday.com, PowerBI, Smartsheet, or similar systems., Accredited Bachelor s degree (or equivalent degree earned outside of the United States) in an engineering field and minimum of 4 years of relevant experience, or advanced degree in an engineering field with a minimum of 2 years relevant experience.