Hardware Technical Architect

Only USC & GC

Position Overview

The Hardware Technical Architect will support Baxter’s Infusion Pump platform, ensuring uninterrupted hardware development, testing, sustenance engineering, and manufacturing support. This role requires strong PCB design expertise, component lifecycle management, and the ability to work cross-functionally across engineering, manufacturing, and vendor teams.

Key Responsibilities

1. Hardware Development & Support

• Ensure seamless business continuity in hardware development, testing, and support for the Baxter Infusion Pump platform.
• Execute hardware changes including PCB design, schematic updates, layout review, and eBOM maintenance.
• Lead ongoing hardware development activities and implement design improvements.

2. Sustenance Engineering

• Manage component obsolescence, evaluate alternates, and drive redesigns as required.
• Support sustaining product engineering and long-term hardware lifecycle management.

3. Manufacturing & Design Transfer

• Collaborate with manufacturing teams for design transfer activities.
• Provide engineering support for production builds, troubleshooting, and yield improvements.

4. Vendor & Stakeholder Coordination

• Work closely with external vendors for components, PCB fabrication, and hardware services.
• Assist in onboarding new internal team members and ensure smooth knowledge transfer.

5. Cross-Functional Collaboration

• Participate in TRB/CCB/CIT cross-functional discussion forums.
• Conduct and contribute to technical design reviews and final design reviews.
• Support risk assessment reviews (PRR, EBRR) and drive mitigation actions.

General Requirements

• Excellent communication skills and ability to collaborate with cross-functional engineering, quality, and manufacturing teams.
• Strong understanding of medical device hardware development processes.
• Experience working in regulated environments (preferably FDA/IEC 60601 standards).