Senior R&D Manager

• Lead, mentor, and develop the Electrical Engineering, Firmware, and Mechanical Engineering teams
• Drive professional development through coaching, goal setting aligned with business objectives, and performance management
• Build organizational capability by identifying skill gaps and recruiting top engineering talent across Electrical, Firmware, and Mechanical disciplines
• Advocate for team needs, including budget, tools, infrastructure, and process improvements
• Lead engineering execution across new product development and sustaining projects, ensuring alignment with Baxter’s strategic priorities
• Ensure the application of best practices in system design, including electrical, firmware, and mechanical integration for medical devices
• Contribute to and review user needs, system requirements, design outputs, and verification/validation plans to ensure quality and compliance
• Drive design for manufacturability, reliability, and serviceability in collaboration with Manufacturing Operations
• Ensure compliance with Baxter’s Quality Management System and all applicable regulatory requirements
• Promote and enforce efficient, value-added engineering processes while maintaining compliance with design control standards
• Collaborate closely with Software Engineering, Regulatory/Quality, Manufacturing, Systems Engineering, and Marketing teams to ensure successful product delivery.
• Serve as a key technical and organizational interface across functions, resolving complex issues and aligning priorities.

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or other related technical discipline
• 10+ years of product development experience, including electrical, mechanical, and/or electromechanical hardware systems
• 5+ years of engineering leadership experience managing multidisciplinary hardware development teams
• Proven experience leading new product development from concept through commercialization and sustaining engineering activities
• Demonstrated success developing connected, embedded, or medical device hardware systems in a regulated environment
• Strong understanding of design controls, requirements management, risk management, verification and validation, and product lifecycle management
• Experience with applicable regulatory standards and quality systems, including FDA Quality System Regulation, ISO 13485, and ISO 14971
• Proven ability to lead, influence, and collaborate across cross-functional teams including Software, Systems Engineering, Manufacturing, Quality, Regulatory, Clinical, and Supply Chain organizations
• Strong communication, talent development, organizational, and strategic planning skills.

Demonstrates expertise in leading multidisciplinary engineering teams in the development of medical devices, ensuring compliance with regulatory standards and best practices in system design. Proven ability to drive product development from concept to commercialization while fostering talent development and organizational capability.

• Electrical Engineering
• Mechanical Engineering
• Firmware Development
• Product Development Leadership
• Regulatory Compliance

• Product Development
• System Design
• Design Controls
• Verification and Validation
• Risk Management
• Requirements Management
• Product Lifecycle Management
• Embedded Systems
• Medical Device Development
• Manufacturability Design

• Leadership
• Talent Development
• Strategic Planning
• Communication
• Collaboration

• Medical Devices
• Regulated Environment
• Cross-Functional Collaboration
• Engineering Processes
• Sustaining Engineering

• Quality Management System
• FDA Quality System Regulation
• ISO 13485
• ISO 14971