Summary:

This role oversees the entire lifecycle of medical device hardware platforms, from design to production and customer support. You'll lead development of new platforms, manage existing ones, and ensure quality and safety throughout.

Responsibilities:

• Manage projects and create work plans based on performance metrics.
• Design new hardware platforms (electrical & mechanical) using internal or external resources.
• Manage product changes, including implementation and tracking.
• Oversee production transitions and new product assembly.
• Troubleshoot quality issues and keep production lines running.
• Analyze production failures and implement solutions to improve quality.
• Ensure design compliance with industry standards and manage external testing.
• Manage subcontractors for assembly, parts, and production processes.
• Improve product robustness through system testing.
• Lead cost reduction efforts for hardware components.
• Address system-related issues at customer sites.

Requirements:

• 5+ years' experience as a system engineer with multi-disciplinary systems.
• Bachelor's in Engineering, Master's preferred.
• Proven experience in mechanical design (SolidWorks).
• Experience with IT-based systems and electrical safety standards (IEC 60601, etc.).
• Experience in manufacturing and working with external vendors.
• Hands-on experience with hardware assembly and system integration.
• Medical device experience and electronic development a plus.
• Excellent communication skills (written & verbal).
• Willingness for periodic travel to production facility.