Senior R&D Manager

Jobtailor; Bellevue (WA); On-site; USD 180,000 - 240,000; Full time

Job summary

Baxter is seeking a senior engineering leader to guide Electrical, Firmware, and Mechanical teams in medical device development. You will mentor multiple disciplines, drive the pace of product delivery, and ensure alignment with regulatory and quality systems.

You will build capability, recruit top talent, manage budgets, and partner with Software, Regulatory/Quality, Manufacturing, and Marketing to deliver compliant, high-quality devices.

Qualifications

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or related technical discipline.
• 10+ years of product development experience across electrical, mechanical, and/or electromechanical hardware systems.
• 5+ years of engineering leadership experience managing multidisciplinary hardware teams.
• Proven experience leading NPD from concept to commercialization and sustaining engineering.
• Experience with regulated medical device hardware development and design controls.

Responsibilities

• Lead, mentor, and develop the Electrical, Firmware, and Mechanical Engineering teams.
• Drive development through coaching, goal setting, and performance management.
• Recruit top engineering talent across Electrical, Firmware, and Mechanical disciplines.

Skills

Leadership

Strategic Planning

Communication

Talent Development

Collaboration

Education

Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or related technical discipline

Tools

Quality Management System

FDA Quality System Regulation

ISO 13485

ISO 14971

Job description

• 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.

Requirements

• 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.

Core Competencies

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.

Highest-signal resume keywords

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

ATS Optimization Keywords

Hard Skills

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

Soft Skills

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

Industry Keywords

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

Tools & Technologies

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