Smith+Nephew is looking for a Senior Systems V&V Engineer to join their Systems Test team to help deliver medical devices to the market and work with globally distributed product development teams to deliver new product solutions. The role is also expected to play an active role in Agile Transformation efforts 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 identification and delivery of all activities necessary, via implementation and management of the technical project plan and inputs, to drive design and development through to production.
- Define and manage the overall technical plan and schedule for designing and developing products while ensuring the plan and strategy are reviewed and agreed upon within the NPD team.
- Drive resolution of test-related issues by facilitating root cause analysis and corrective actions across engineering and quality teams.
- Ensure traceability between requirements, test protocols, and results to support regulatory submissions and audits.
- Coordinate with test engineering to ensure adequate resources (equipment, personnel, lab space) are available to meet verification timelines.
Other
- Lead internal and external teams to deliver results per product requirements.
- Help build and maintain Agile Product Backlogs.
- 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.
- Work effectively cross-functionally with Clinical, Design & Usability, Marketing, R&D, Quality, and Regulatory and others to ensure technical inputs and outputs are considered and accounted for in project plans.
- Report progress regularly to management and the project core team.
- Outstanding communication, facilitation, and coaching skills.
- Experience presenting to executive-level management on project status.
- Domestic / International – up to 15% travel requirements.
