Smith & Nephew - Pittsburgh, PA

posted 4 months ago

Full-time - Mid Level
Pittsburgh, PA
Merchant Wholesalers, Durable Goods

About the position

As a Senior Hardware Test Engineer at Smith+Nephew, you will play a pivotal role in the development and verification of our cutting-edge surgical robotics platform. Your primary responsibilities will include generating comprehensive verification test plans and completing detailed test protocols. You will also be responsible for creating and leading design input requirements, ensuring that they are clear and testable. This position requires you to take a lead role within the Hardware Test Engineering team, where you will mentor junior staff members and provide leadership to continuously improve hardware testing processes and procedures. You will collaborate with a highly talented team to develop innovative products in the rapidly growing orthopedic robotic surgery market. In this role, you will create design input requirements for new product development activities, focusing on clarity and testability. You will develop test cases that accurately depict the methods and techniques necessary to validate our medical device designs against relevant standards set by external regulatory groups such as ISO, IEC, and FDA. Additionally, you will develop and implement test methods to conduct verification tests of medical devices and accessories, selecting appropriate test equipment and supplies while evaluating designs. Your responsibilities will also include reviewing agency specifications and structuring device test cases in accordance with these requirements. You will write subsystem and system-level test protocols and reports, work on project teams to ensure timelines are met, and document test results with formal engineering reports. Participation in design reviews and providing guidance to test technicians and junior engineers will also be key aspects of your role.

Responsibilities

  • Generate verification test plans and complete test protocols.
  • Create and lead design input requirements for new product development.
  • Develop test cases to validate medical device designs against regulatory standards.
  • Implement test methods for verification tests of medical devices and accessories.
  • Select test equipment and supplies for testing.
  • Review agency specifications and structure device test cases accordingly.
  • Write subsystem and system-level test protocols and reports.
  • Collaborate with project teams to meet project timelines.
  • Document test results with formal engineering reports.
  • Participate in design reviews as required.
  • Provide guidance and direction to Test Technicians and junior engineers.

Requirements

  • Bachelor of Science in Electrical Engineering strongly preferred.
  • Minimum of 5 years of Test Engineering experience, including design, documentation, and validation of test systems and hardware.
  • Ability to read and interpret CAD drawings to component level.
  • Proficient with common software packages (MS Office, spreadsheets, presentations, etc.).
  • Strong statistical analysis skills required (Gage R&R study, Design of Experiments, Probability Distribution, etc.).
  • Understanding of operation of electromechanical devices.
  • Fundamental knowledge of programming instrumentation and hardware used in testing electrical subassemblies and devices.
  • Design Control experience from a regulated industry (Medical Device or Pharmaceuticals).
  • LabVIEW experience is preferred.

Nice-to-haves

  • Experience in verification and validation testing of electromechanical devices.
  • Test experience related to new product development and sustaining products.

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 (Employer Contribution of $500+ annually)
  • Employee Assistance Program
  • Parental Leave
  • Fertility and Adoption Assistance Program
  • Hybrid Work Model
  • Discounts on fitness clubs, travel, and more!
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