Systems Engineer (Pittsburgh, PA)

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?

• BS in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, or Biomedical Engineering with 2+ years in system testing or medical device development required
• MS or PhD 1+ years in system testing or medical device development preferred
• Working knowledge of systems engineering and product development lifecycle (requirements, interfaces, verification) in regulated industries
• Demonstrated ability to lead project team
• 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

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.
• INCOSE certification is a plus

Competencies:

• 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

Travel:

• Domestic / International – up to 15%

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

• Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, 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 <