Senior Hardware Test Engineer (Pittsburgh, PA)

Smith & Nephew - Pittsburgh, PA

Full-time - Mid Level

Hybrid - Pittsburgh, PA

Merchant Wholesalers, Durable Goods

About the position

The Robotics Hardware Test Engineer at Smith+Nephew is responsible for generating and implementing test protocols for innovative surgical robotics platforms. This role involves leading verification and validation testing, maintaining the product's risk management file, and formulating test procedures to ensure high-quality designs while adhering to regulatory standards throughout the product life cycle.

Responsibilities

• Design test fixtures and develop new test methods.
• Document the design of test fixtures and run test method validations.
• Develop test cases to validate medical device designs against external regulatory standards such as ISO, IEC, and FDA.
• Write test procedures to verify operation, usability, performance, and reliability of systems.
• Execute test plans and document test results.
• Create documented bug reports for anomalies found during testing.
• Verify bug fixes and document results accordingly.
• Trace requirements and bug fixes to test reports demonstrating proper operation after fixes.
• Adhere to quality system requirements and support compliance with domestic and international regulations.
• Mentor and provide training to less experienced peers.

Requirements

• Bachelor's degree in Electrical, Mechanical, Computer Engineering or related field.
• 5+ years in a regulated product development environment.
• Strong competence and interest in product design assurance and testing.
• Experience in project management, human factors engineering, and risk assessment.
• Experience using Linux/Unix is desirable.
• Experience using SolidWorks / Labview is desirable.

Nice-to-haves

• Experience in cadaver labs or operating room settings.

Benefits

• 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 Insurance
• Health Savings Account with Employer Contribution
• Employee Assistance Program
• Parental Leave
• Fertility and Adoption Assistance Program
• Hybrid Work Model
• Discounts on fitness clubs and travel.