Senior Hardware & Embedded Systems Manager

Baxter International Inc.; Bellevue (WA); On-site; USD 152,000 - 209,000; Full time

Benefits offered by this job

Health and dental benefits

401(k) with company match

Employee Stock Purchase Plan (ESPP)

Generous paid time off

Educational assistance

Job summary

Baxter International Inc. in Bellevue seeks a Senior Engineering Manager to lead Electrical, Firmware, and Mechanical Engineering teams, reporting to the Senior Director of R&D.

You will drive new product development and sustaining engineering for medical devices, ensuring quality, regulatory compliance, and cross-functional collaboration across Software, Regulatory/Quality, Manufacturing, Systems Engineering, and Marketing.

Qualifications

• 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 FDA Quality System Regulation, ISO 13485, and ISO 14971.

Responsibilities

• Lead, mentor, and develop Electrical, Firmware, and Mechanical Engineering teams to foster high performance.
• Drive product development programs and sustaining engineering initiatives across multiple disciplines.
• Ensure compliance with Baxter’s Quality Management System and regulatory requirements.
• Collaborate with Software, Regulatory/Quality, Manufacturing, Systems Engineering, and Marketing to deliver products.

Skills

Leadership

Cross-functional collaboration

Embedded systems

Regulatory/compliance knowledge

Education

Bachelor's degree in Electrical/Mechanical/Biomedical Engineering or related field

Job description

Baxter International Inc. in Bellevue seeks a Senior Engineering Manager to lead Electrical, Firmware, and Mechanical Engineering teams, reporting to the Senior Director of R&D.

You will drive new product development and sustaining engineering for medical devices, ensuring quality, regulatory compliance, and cross-functional collaboration across Software, Regulatory/Quality, Manufacturing, Systems Engineering, and Marketing.