Senior Systems Engineer (Pittsburgh, PA)

Smith & Nephew•Pittsburgh, PA

1d•Hybrid

About The Position

Senior 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 Senior 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 lead the 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: Create and maintain physical and functional product architecture to define system interactions, user workflows, and functional boundaries. System Integration & V&V: Lead the integration of hardware and software subsystems and ensure robust system-level verification and validation. Innovation & Process Improvement: Champion advanced systems engineering practices such as Model-Based Systems Engineering (MBSE), modular design, simulation, and AI assist 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: Lead technical and regulatory risk analysis and mitigation throughout the development lifecycle. Design Control & Quality: Partner with Design Quality Assurance to implement and improve engineering and design control processes. Mentorship & Leadership: Provide technical leadership across R&D and mentor junior engineers in systems engineering best practices. What will you need to be successful?

Requirements

BS in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, or Biomedical Engineering with 6+ years in system testing or medical device development required
Experience with system integration and verification in regulated environments.
Proven leadership in systems engineering / product development
Proficient in requirements management and modeling tools (e.g., DOORS, Cockpit, Enterprise Architect, PTC Integrity).
Knowledgeable in typical medical device development and safety standards (e.g. 60601, 14971, 62304, 62366, etc)
Skilled in the application of statistical techniques for error budgeting, sample size determination and test data analysis.
Skilled in system modeling using SysML, UML, or equivalent.
Familiar 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.

Nice To Haves

MS or PhD with 3+ 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
Experience using state of the art technologies to improve process efficiency and overall productivity (AI/ML)
Knowledge of Design for Reliability and Design for Six Sigma practices.
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: Create and maintain physical and functional product architecture to define system interactions, user workflows, and functional boundaries.
System Integration & V&V: Lead the integration of hardware and software subsystems and ensure robust system-level verification and validation.
Innovation & Process Improvement: Champion advanced systems engineering practices such as Model-Based Systems Engineering (MBSE), modular design, simulation, and AI assist 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: Lead technical and regulatory risk analysis and mitigation throughout the development lifecycle.
Design Control & Quality: Partner with Design Quality Assurance to implement and improve engineering and design control processes.
Mentorship & Leadership: Provide technical leadership across R&D and mentor junior engineers in systems engineering best practices.