Smith+Nephew is looking for a Senior Systems V&V Engineer to join their Systems Test team to deliver new product solutions and contribute to Agile Transformation efforts, aiming to build a high-performance product development team.
Requirements
- Tools Experience: Jira, Cockpit, Windchill, or other requirements management, test management, and work management tools.
- Authoritative knowledge in SAFe, SCRUM, or related Agile frameworks and methodologies.
- Understanding of the application of ISO 13485, IEC62304, and FDA QS Regulation 21 CFR Part 820.
- Experience with product development involving hardware, firmware, and software elements.
- 6+ years of experience in delivering medical device solutions to production with a BS degree (3+ years with a MS degree).
- 3+ years of experience in medical device verification & validation testing.
Responsibilities
- Create and manage system-level test protocols and test cases to ensure traceability to requirements.
- Execute system-level verification and validation tests.
- Ensure traceability between requirements, test protocols, and results to support regulatory submissions and audits.
- Drive resolution of test-related issues by facilitating root cause analysis and corrective actions across engineering and quality teams.
- Coordinate with test engineering to ensure adequate resources (equipment, personnel, lab space) are available to meet verification timelines.
- Define and track key performance indicators (KPIs) such as test coverage, defect density, on-time sprint delivery, and verification cycle time to drive continuous improvement.
- Help build and maintain Agile Product Backlogs.
Other
- BS in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, or Biomedical Engineering.
- MS or PhD in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, or Biomedical Engineering preferred.
- Outstanding communication, facilitation, and coaching skills.
- Experience presenting to executive-level management on project status.
- Domestic / International – up to 15%.
