Systems Engineer (Pittsburgh, PA)

Smith & Nephew•Pittsburgh, PA

1d•Hybrid

About The Position

Systems Engineer (Pittsburgh, PA) Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Join our Robotics R&D team as a Systems Engineer, where you will play a critical role in shaping the future of surgical robotics and digital surgery enablers. This highly visible position reports to the Manager of Systems Engineering and is responsible for delivering on a multi-generational innovation roadmap for our Robotics Surgical Systems and Real Intelligence platforms. You will contribute to definition, integration, and verification of complex electromechanical and software systems, collaborating across R&D, Marketing, Clinical, Quality, and Regulatory teams to ensure successful product development and global compliance. What will you be doing? Stakeholder Needs and Requirements Engineering: Partner with global marketing and clinical teams to capture voice of customer and translate into actionable system requirements. Apply Stakeholder Needs Gathering and Decision Management techniques to prioritize features. Architecture Definition: Participate in creation and maintenance of physical and functional product architecture to define system interactions, user workflows, and functional boundaries. System Integration & V&V: Support the integration of hardware and software subsystems and ensure robust system-level verification and validation. Innovation & Process Improvement: Contribute to systems engineering functional excellence and continuous improvement initiatives such as Agile product development, Model-Based Systems Engineering, and use of AI for product development. Cross-Functional Collaboration: Engage with cross-functional teams to ensure products are designed for functionality, security, reliability, scalability, usability, manufacturability, and serviceability. Risk Management: Contribute to technical and regulatory risk analysis and mitigation throughout the development lifecycle. Design Control & Quality: Prepare and control Medical Device File (MDF) deliverables in accordance with Quality Management System procedures. What will you need to be successful?

Requirements

BS in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, or Biomedical Engineering with 2+ years in system testing or medical device development required
Working knowledge of systems engineering and product development lifecycle (requirements, interfaces, verification) in regulated industries
Demonstrated ability to lead project team
Technical Skills: Experience with requirements and test management tools (e.g., DOORS, Cockpit, Enterprise Architect, PTC Integrity).
Familiarity with typical medical device development and safety standards (e.g. 60601, 14971, 62304, 62366, etc)
Exposure to system modeling using SysML, UML, or equivalent.
Familiarity with SAFe or Agile development methodologies.
Entrepreneurial mindset with strong communication and stakeholder engagement skills.
Ability to thrive in a fast-paced, results-driven environment.
Ability to use state of the art technologies (AI/ML) to improve process efficiency

Nice To Haves

MS or PhD 1+ years in system testing or medical device development preferred
Previous development experience on products with the following characteristics preferred: Products/Systems which store and transmit protected data Cloud-based web applications Products with an end-user software UI
INCOSE certification is a plus

Responsibilities

Stakeholder Needs and Requirements Engineering: Partner with global marketing and clinical teams to capture voice of customer and translate into actionable system requirements. Apply Stakeholder Needs Gathering and Decision Management techniques to prioritize features.
Architecture Definition: Participate in creation and maintenance of physical and functional product architecture to define system interactions, user workflows, and functional boundaries.
System Integration & V&V: Support the integration of hardware and software subsystems and ensure robust system-level verification and validation.
Innovation & Process Improvement: Contribute to systems engineering functional excellence and continuous improvement initiatives such as Agile product development, Model-Based Systems Engineering, and use of AI for product development.
Cross-Functional Collaboration: Engage with cross-functional teams to ensure products are designed for functionality, security, reliability, scalability, usability, manufacturability, and serviceability.
Risk Management: Contribute to technical and regulatory risk analysis and mitigation throughout the development lifecycle.
Design Control & Quality: Prepare and control Medical Device File (MDF) deliverables in accordance with Quality Management System procedures.