Specialist - Drug Delivery Devices

Job Description

• Device Design & Engineering : Develop advanced wearable infusion pump based drug delivery systems.
• Sensor & Embedded Systems Integration : Implement microcontrollers, infusion mechanism (motor), biosensors, memory storage, real time clock, and real-time monitoring for drug delivery precision.
• Power Management & Miniaturization : Optimize battery life and ergonomic design for portable use.
• User interface (UI) Design : Ensure accessibility with clear visuals, alerts, and simple navigation and focus on Intuitive design, buttons, real-time display, customizable settings, alarms, emergency alerts
• Testing & Validation : Conduct bench, preclinical, and clinical device performance assessments. Develop and implement robust testing strategies to assess the performance, safety, and efficiency of combination products. Application of AAMI TIR101, ANSI / AAMI SW96, ISO 8536-8, ISO 8536-9, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-2-24, IEC 62366-1.
• Cross-Functional Collaboration : Work closely with pharmaceutical teams, software engineers, clinical researchers, and regulatory affairs specialists.
• Regulatory Compliance : Ensure adherence to ISO 13485, 510(k), CE mark, FDA 21 CFR Part 4 and other relevant regulatory and quality compliance.
• Manufacturing & Scalability : Support prototyping, testing, and production scale-up for commercial viability.
• Develop and maintain essential documentation, including design and development plans, design history files, and traceability matrices. Actively participate in and drive design reviews and design change controls.
• Manage vendor interactions and communication for notified body opinion, device suppliers, packaging component suppliers, human factors, user research, and visual design.
• Application of risk management for infusion pump development : risk identification, risk analysis, risk evaluation, risk control measures, residual risk assessment
• Participates and leads product quality investigations to identify root cause and implement corrective actions. Supports the management of exception documents and Corrective and Preventive Actions.
• Drive program execution excellence while ensuring efficient and timely escalation of urgent issues / risks to leadership.

Qualifications

Skills Required

Statistical Analysis, Microcontrollers, Quality Management, design controls , Data Interpretation, Ui Design, Risk Management, Experimental Design, Regulatory Compliance, biosensors