Senior Systems V&V Engineer, Robotics Systems Test (Pittsburgh, PA)
Smith & Nephew10 months ago
Pittsburgh, PA, United States
Hybrid
Full-time
Junior Level (1-3 years)
Job Description
Position Overview
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 also 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.
Key Responsibilities
- 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.
- Manage technical project plans to guide design and development through to production.
- Define and manage the overall technical plan and schedule for designing and developing products while ensuring alignment with the NPD team.
- Collaborate cross-functionally with Clinical, Design & Usability, Marketing, R&D, Quality, and Regulatory teams to integrate technical inputs and outputs in project plans.
- Report progress regularly to management and the project core team.
Required Qualifications
- BS in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, or Biomedical Engineering.
- 6+ years of experience in delivering medical device solutions to production with a BS degree (or 3+ years with a MS degree).
- 3+ years of experience in medical device verification & validation testing.
- Experience with tools such as Jira, Cockpit, Windchill, or other requirements, test, and work management systems.
- Outstanding communication, facilitation, and coaching skills.
- Authoritative knowledge in SAFe, SCRUM, or related Agile frameworks and methodologies.
- Understanding of ISO 13485, IEC62304, and FDA QS Regulation 21 CFR Part 820.
- Experience with product development involving hardware, firmware, and software elements.
- Experience presenting project status to executive-level management.
Preferred Qualifications
- MS or PhD in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, or Biomedical Engineering.
Benefits & Perks
- 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!
Required Skills
Test Protocol Development
Systems Test Management
IEC62304
Jira
Cross-functional Team Leadership
SAFe
Agile Transformation
Cockpit
Windchill
Technical Project Planning
Medical Device Development
SCRUM
Verification & Validation Testing
Agile Methodologies
FDA 21 CFR Part 820
ISO 13485