Engineering Lead, Systems Engineer, Biomedical Engineer

We are an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent, and innovation, our extensive range of products, services, and integrated technologies fuels active lifestyles in orthopedics and beyond.

We are an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent, and innovation, our extensive range of products, services, and integrated technologies fuels active lifestyles in orthopedics and beyond.

We are seeking an experienced and collaborative
Technical Lead to provide multidisciplinary leadership for the development and delivery of next-generation orthopedic technologies.

In this role, you will deliver system-level technical direction from concept through commercialization. Your primary focus will center on
augmented reality (AR) navigation or
integration of navigation with robotic systems . You will lead technical execution across electrical, mechanical, software, materials, biomedical, and systems engineering disciplines to translate clinical needs into safe, effective, and commercially viable medical devices.

Key Responsibilities
Technical Leadership:
Serve as the primary technical authority for multidisciplinary enabling technologies, guiding system architecture, interfaces, coordinate systems, tracking, instrumentation, workflow, and control functions.
System Integration:
Lead technical execution that translates clinical concepts and user needs into complete medical device products, defining subsystem interactions, performance requirements, and system behavior.

Cross-Functional Collaboration:

Partner with Clinical, Product Management, Systems Engineering, Quality, Regulatory Affairs, Manufacturing, and Program Management to align clinical/business objectives into technical architectures and executable plans.
Regulatory & Quality Compliance:
Support technical design throughout the product development lifecycle, ensuring adherence to FDA, EU MDR, IEC, and ISO standards.
Risk & Lifecycle Management:
Identify technical risks across hardware, software, algorithms, and clinical workflows; develop robust mitigation strategies; and oversee verification, validation, usability engineering, and design transfer.
Team Mentorship:
Coach and mentor multidisciplinary engineering teams to foster technical excellence, innovation, and sound engineering practices.
Technology

Roadmap:

Evaluate emerging technologies in augmented reality, navigation, AI, sensors, visualization, and automation for future product pipelines.

• Education: Bachelors degree in Engineering (Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or related technical field).
• Experience: 6+ years of experience developing complex medical devices or related technology products.
• Leadership: Proven experience leading multidisciplinary engineering teams and complex projects.
• Technical Depth: Strong background in systems engineering, integrating software, electronics, mechanical hardware, and algorithms.
• Design Controls: Solid understanding of medical device design controls, technical risk management, V&V, and product lifecycle management.
• Travel Requirements: Ability to obtain and maintain a valid passport for international business travel as needed.

• Masters degree in an Engineering or technical discipline.
• Direct experience developing orthopedic navigation, visualization, image-guided surgical systems, or surgical robotics.
• Expertise in computer vision, sensor fusion, inertial navigation, optical tracking, image processing, or mechatronics/automation.
• Hands-on experience with capital medical equipment or orthopedic instrumentation.
• Strong familiarity with regulatory standards:
  IEC 62304, ISO 13485, ISO 14971, IEC 60601 series, FDA Design Controls, and EU MDR
  .
• History of taking
  Class II and/or Class III medical devices from concept to successful commercialization.
• Issued patents or demonstrated track record of technical innovation.

• Technical Leadership & Strategy: Provides clear architectural vision while driving engineering excellence aligned with…