Job Description:
We are seeking a hands-on, technically accomplished, Mechanical Engineer. This individual will Create mechanical design of complex infusion hardware with core focus on including their loading, actuation, safety systems, and performance under all clinical conditions.
Key Responsibilities:
• Create the mechanical design of complex infusion hardware with core focus on:
• Pumping mechanism design and optimization
• Fluid path layout and actuation systems
• Loading interfaces that ensure intuitive, error-proof use
• Safety-critical features such as anti-flowback, occlusion protection, and alarm actuation
• Ensure robust performance under variable real-world conditions, including variations in viscosity, backpressure, orientation, mobility, and power availability.
• Guide integration of sensing and feedback systems (e.g., pressure, flow, torque) into mechanical assemblies to support closed-loop control, dosage accuracy, and error detection.
• Apply advanced engineering tools and practices, including FEA, FMEA, and risk-based design to deliver high-reliability, manufacturable solutions.
• Ensure all designs comply with regulatory and quality standards, including FDA, ISO 13485, and IEC 60601.
Qualifications
• Bachelor’s or Master’s degree in Mechanical Engineering or closely related field.
• 5+ years of mechanical design experience in complex hardware development, preferably in medical devices or regulated industries.
• Strong knowledge of medical-grade materials, fluid interfaces, sensor integration, and design for high-volume manufacturing.
• Exposure to Agile hardware development, Six Sigma (Green/Black Belt), and lean engineering preferred.
• Proven track record of technical ownership and product delivery in fast-paced development environments
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