Staff Systems Verification Engineer (Pittsburgh, Pa)

Staff Systems Verification Engineer (Pittsburgh, PA)
Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.
You will be part of a very talented team that is highly motivated and passionate about our vision which simply is "Life Unlimited". The position is in Pittsburgh, PA which is rapidly becoming the premier location for everything Robotics. You will take great pride in seeing the impact of everything you are involved in developing, having a tremendous impact on lives of patients and clinicians.
Systems Verification engineers serve as the safety net for the entire organization before shipping products to the customer. This Staff Systems Verification Engineer works with the systems engineers, software product owner, software, and hardware development engineers to drive and lead the test strategy for system verification & validation and execution for the new product development.
What will you be doing?

• Manage and own all aspects of system verification & validation for new product development.
• Participate in requirements discussions and provide input to testability of requirements as necessary. Understand impact of detailed design on the overall system to create detailed test strategies.
• Manage all aspects of verification testing, including determining sample sizes, creation, management and ownership of testing strategy, integration testing, robustness testing strategies, and defect management.
• Identify and lead initiatives such as Test Automation, Automated Test Case development.
• Author verification plans, protocols, test cases, summary reports, traceability matrix and other related technical documentation.
• Plan, develop and execute verification testing (both manual and automated) for medical devices, based on context and risks associated with the project.
• Support troubleshooting and root cause analysis of system defects and enable R&D team to identify fixes.
• Identify, report, track, and prioritize HW/SW defects using defects management systems (e.g. JIRA) and validate fixes.
• Work with geographically distributed test engineering team to allocate and manage testing resource needs.
• Present testing objectives and status at planning meetings. Report on testing progress on monthly test dashboard and to upper management.
• Participate in design reviews, design FMEA, and support the development of documentation required for FDA / EU MDR device clearance.
• Manages test equipment for test efforts, ensuring complete and accurate inventory along with production equivalence.

What will you need to be successful?

• Bachelor of Science/Engineering degree in Electrical, Biomedical or Computer Engineering or related field. Graduate degree is highly preferred.

• 8+ years of experience in R&D with a track record of bringing complex products to the market
• 4+ years of experience in test verification and validation
• 2+ years of experience in the medical device field or other regulated field

• Experience in developing sophisticated products that includes hardware, electrical and software.

• Experience with test strategy development and execution across a range of electromechanical products, including test automation, performance testing, negative testing, code and coverage analysis, and compatibility testing.
• Experience with embedded software programming, application software programming of test automation & test frameworks.

• Experience in software development and test processes.

• Solid understanding of quality systems and quality assurance processes and principles, with a focus on development and/or verification/validation activities.
• Experience with Agile in a regulated field (preferably medical devices)

• Solid understanding of reliability engineering, including developing reliability plans for product development, accelerated life testing design and analysis, reliability analysis and prediction.
• Detailed understanding of IEC 62304, ISO 14971, IEC 60601, FDA and MDD/MDR design control requirements for medical devices.
• Experience using JAMA/Cognition or similar tools for requirements/test management.
• Solid understanding of test automation/code coverage tools including MATLAB, LabVIEW, LDRA, or other tools.
• Knowledge of Linux/Unix operating systems.

• May require attendance in cadaver labs or operating room setting

You Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

• Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/)
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

Smith+Nephew is committed to the full inclusion of all qualified individuals. As part of this commitment, Smith+Nephew will ensure that persons with disabilities are provided reasonable accommodations. If reasonable accommodation is needed, please alert the recruiter if you are selected to move forward.
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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