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? BS in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, or Biomedical Engineering with 6+ years in system testing or medical device development required MS or PhD with 3+ years in system testing or medical device development preferred Experience with system integration and verification in regulated environments. Proven leadership in systems engineering / product development 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) Technical Skills: 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. Knowledge of Design for Reliability and Design for Six Sigma practices. 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. 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 Flexibility: Hybrid Work Model (For most professional roles) Training: Hands-On, Team-Customized, Mentorship Extra Perks: Discounts on fitness clubs, travel and more! #LI-HYBRID Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability. Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer. Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.

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.