Hardware Systems Engineering Manager

Overview

A leading organization in the medical technology space is seeking a Hardware Systems Engineering Manager to guide a multidisciplinary team developing next-generation surgical navigation platforms. This role blends strong mechanical and electrical engineering expertise with systems-level thinking and leadership in a regulated environment.

• Hardware & System Development – Lead the creation of complex hardware platforms, including mechanical assemblies, electrical subsystems, and electromechanical components.
• Oversee design efforts spanning precision mechanisms, materials selection, PCB development, power management, and sensor integration.
• Ensure hardware solutions meet demanding performance, reliability, and safety expectations.
• Define and drive system-level architecture for integrated surgical navigation hardware.
• Ensure seamless interaction between mechanical, electrical, software, and clinical components.
• Manage system requirements, risk analysis, and verification/validation processes across the product lifecycle.
• Recruit, develop, and mentor a high-performing team of hardware and systems engineers.
• Promote a culture of innovation, accountability, collaboration, and high-quality engineering execution.
• Maintain alignment with timelines, budgets, and quality objectives in a regulated environment.

• Process Excellence & Compliance – Implement rigorous systems engineering methodologies including requirements traceability, design controls, and documentation best practices.
• Ensure alignment with medical device standards such as ISO 13485 and IEC 60601.
• Support the transition of designs from R&D through manufacturing under established regulatory guidelines.

• Innovation & Technical Advancement – Identify emerging technologies that can influence or enhance future product roadmaps.
• Lead prototyping, feasibility studies, and early-stage evaluations of new navigation and sensing technologies.
• Encourage intellectual property development and continuous technical improvement.

• Master’s degree or PhD in Mechanical Engineering, Electrical Engineering, or a related field.
• 8+ years of experience in systems or hardware engineering with strong mechanical and electrical foundations.
• 3+ years of leadership experience within regulated industries (medical device experience preferred).
• Expertise in mechanical design (CAD, tolerance analysis, materials) and electrical design (schematics, PCB layout, power systems).
• Strong background in system integration, architecture, and full lifecycle development.
• Experience with medical devices, navigation systems, imaging, robotics, sensing, or real-time control technologies is a plus.
• Knowledge of regulatory frameworks including FDA requirements, IEC 60601, and risk management practices.
• Exceptional communication, leadership, and cross-functional collaboration skills.