Lead Systems Engineer

Role: Lead Systems Engineer

Location: Kharadi, Pune

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.

Join our dynamic ENT R&D team where cutting-edge technology meets rigorous validation. As an experienced Lead Systems Engineer to drive systems engineering activities for New Product Development (NPD) of advanced medical devices, with a strong emphasis on electrical systems for Electrosurgical devices. This role requires expertise with extensive knowledge in systems architecture, electrical design, embedded firmware, and adherence to medical device standards (e.g., IEC 62304, IEC 60601, ISO 13485, ISO 14971, etc). The Lead Systems Engineer will coordinate interdisciplinary activities across electrical, software, mechanical, and testing domains, mentor teams and drive innovation and execution in regulated environments for complex electrosurgical systems.

What will you be doing?

• Systems Engineering Technical Oversight: Drive systems engineering activities and technical aspects of new product development programs in collaboration with technical leads (hardware, software, testing, etc.), program managers, and cross-functional teams with a focus on electrical integration and performance.

• Requirements and Architecture Development: Support the development of system, software, electrical, and accessory requirements. Define system architecture, including functional, physical, electrical, and interface specifications, for complex products involving hardware, embedded firmware, and electrical components in RTOS and bare-metal environments.

• Electrical Design and Integration: Drive interdisciplinary activities for electrical, mechanical, and software development, emphasizing electrical circuit design, power management, signal processing, and hardware-software interfaces. Support integration activities, including defining electrical integration goals, success criteria, and troubleshooting for electrosurgical instruments.

• Verification and Validation: Develop verification and validation strategies in collaboration with test teams to ensure functional, electrical, and safety requirements are met. Analyze system performance, including electrical algorithms and data processing, across embedded platforms. Support benchtop and other testing activities, ensuring electrical reliability and performance in regulated settings.

• Risk Management and Evaluation: Analyze product and project risks throughout development, with particular attention to electrical safety and compliance. Support benchtop and other testing, ensuring electrical reliability and performance in regulated settings. Support regression analysis and risk mitigation for electrical updates.

• Team Leadership and Mentorship: Lead and mentor a technical team, providing guidance in systems and electrical engineering, conducting technical reviews, and fostering collaboration with firmware, hardware, and R&D teams. Serve as a resource for best practices in systems and electrical design and testing.

• Innovation and Research: Conduct new technology research in electrical systems to expand into new indications and support the innovation pipeline for medical devices, including advancements in electrosurgical technologies.

• Tool Management and Reporting: Configure and manage systems engineering tools for requirements management (e.g., Cognition Cockpit, Enterprise Architect) and electrical simulation. Generate detailed reports on system architecture, electrical performance, and quality metrics for senior management and stakeholders.

What will you need to be successful?

• BS, MS, or PhD in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, or Biomedical Engineering with proven experience in medical device development.
• Certifications: Certifications such as Systems Engineering Professional (SEP) or equivalent.
• Experience: 6+ years (BS) or 3+ years (MS) degree in Electrical or Systems Engineering, with proven experience in medical device development.
• Track record of technical leadership of large-scale projects in R&D with complex electrical systems, including embedded platforms (RTOS or bare-metal).
• Advanced understanding of medical device standards (e.g., IEC 62304, IEC 60601, ISO 13485, ISO 14971, FDA/MDR guidance).
• Experience with advanced electrical debugging, optimization, and testing in regulated environments.
• Familiarity with electrical safety testing and interdisciplinary product development for electrosurgical applications.
• Strong proficiency in C/C++ for embedded firmware; expert knowledge of electrical design tools and simulation software.
• Mastery of electrical systems in electrosurgical devices, including HIL testing, circuit design, and embedded environments.
• Experience with requirements management tools (e.g., Cognition Cockpit) and model-based systems engineering (e.g., Enterprise Architect).
• Breadth of knowledge across electrical, mechanical, and software engineering fields. Experience with Software as Medical Device (SaMD) is a plus.
• Demonstrated success in delivering innovative medical devices to market, with expertise in electrical design, integration, and system verification.
• Strong problem-solving, analytical, and decision-making skills for complex electrical and systems challenges.
• Exceptional leadership, teambuilding, and communication abilities to influence cross-functional teams.
• Persistent, self-motivated, and able to thrive in a fast-paced, collaborative environment.

You Unlimited.

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

Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving. Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).

Other reasons why you will love it here!

• Your Future: Major medical coverage + policy exclusions and insurance non-medical limit. Educational Assistance.
• Work/Life Balance: Flexible Personal/Vacation Time Off, Privilege Leave, Floater Leave.
• Your Wellbeing: Parents/Parents-in-Law’s Insurance (Employee Contribution of 8,000/- annually), Employee Assistance Program, Parental Leave.
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Free Cab Transport Facility for all employees; One-Time Meal provided to all employees as per shift. Night shift allowances.

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