Senior Medical Device R&D Leader (Electrical/Firmware/Mech)

Zvh; Bellevue (WA); On-site; USD 152,000 - 209,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) with match

Employee stock purchase plan (ESPP)

Job summary

Baxter is seeking a Senior Engineering Manager to lead and develop Electrical, Firmware, and Mechanical Engineering teams at the Bellevue site. You will drive new product development and sustaining engineering, partnering with Software, Regulatory/Quality, Manufacturing, and Marketing to deliver compliant medical devices.

Ideal candidates have 10+ years in product development, embedded hardware expertise, and proven leadership of multidisciplinary teams in regulated environments, with strong

Qualifications

• Bachelor’s degree in Electrical/Mech/BioEng or related field.
• 10+ years product development experience across electrical, mechanical, and/or electromechanical hardware systems.
• 2+ years engineering leadership of 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 regulatory standards and quality systems including FDA QSR/ISO 13485/ISO 14971.
• Ability to lead, influence, and collaborate across cross-functional teams including Software, Systems Engineering, Manufacturing, Quality, Regulatory, Clinical, and Supply Chain.

Responsibilities

• Lead, mentor, and develop Electrical, Firmware, and Mechanical Engineering teams to foster high performance.
• Drive professional development through coaching, goal setting, and performance management.
• Identify skill gaps and recruit engineering talent across electrical, firmware, and mechanical disciplines.
• Drive design for manufacturability, reliability, and serviceability with Manufacturing Operations.
• Ensure compliance with Baxter’s Quality Management System and regulatory requirements.
• Collaborate with Software, Regulatory/Quality, Manufacturing, Systems Engineering, and Marketing to ensure successful product delivery.

Skills

Leadership

Embedded systems

Electromechanical hardware

Cross-functional collaboration

Strategic planning

Education

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

Job description

Baxter is seeking a Senior Engineering Manager to lead and develop Electrical, Firmware, and Mechanical Engineering teams at the Bellevue site. You will drive new product development and sustaining engineering, partnering with Software, Regulatory/Quality, Manufacturing, and Marketing to deliver compliant medical devices.

Ideal candidates have 10+ years in product development, embedded hardware expertise, and proven leadership of multidisciplinary teams in regulated environments, with strong