Smith & Nephew-posted 3 months ago
Full-time • Senior
Hybrid • Pittsburgh, PA
Merchant Wholesalers, Durable Goods

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living! We are looking for a passionate and experienced Senior Systems V&V Engineer to join our Systems Test team. The successful candidate will bring a demonstrated track record and experience delivering medical devices to the market and will work with globally distributed product development teams to deliver new product solutions. This leader will work with globally distributed product development teams to deliver new product solutions and is expected to play an active role in Agile Transformation efforts to build a high-performance product development team. The role will report to the Robotics Director of Systems Test.

  • 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.
  • Coordinate with test engineering to ensure adequate resources (equipment, personnel, lab space) are available to meet verification timelines.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Tools Experience: Jira, Cockpit, Windchill, or other requirements management, test management, and work management tools.
  • Outstanding communication, facilitation, and coaching skills.
  • 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.
  • Experience presenting to executive-level management on project status.
  • 401k Matching Program
  • 401k Plus Program
  • Discounted Stock Options
  • Tuition Reimbursement
  • Flexible Personal/Vacation Time Off
  • Paid Holidays
  • Flex Holidays
  • Paid Community Service Day
  • Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually)
  • Employee Assistance Program
  • Parental Leave
  • Fertility and Adoption Assistance Program
  • Hybrid Work Model (For most professional roles)
  • Hands-On, Team-Customized, Mentorship
  • Discounts on fitness clubs, travel and more!
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