Specialist - Drug Delivery Devices

• 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

• Advanced degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related technical discipline with 10+ years of relevant industry experience in wearable injector devices, or advanced drug delivery device development with a major device, pharmaceutical, biotechnological or a generic pharmaceutical company.
• Demonstrated experience in wearable injectors and continuous infusion pump development, including IV infusion sets and primary containers.
• Understanding of system thinking (drug+ primary container+ device) and experience with human factors/ usability engineering.
• Experience with the development of connected devices is desirable but not required.
• Strong expertise in experimental design, statistical analysis, and data interpretation.
• Experience working within device standards: Design Controls (US FDA QMSR), Risk Management (ISO 14971); Quality Management (ISO 13485); Good Manufacturing Practices (21 CFR Part 4, 21 CFR 210/211, 21 CFR 820); EU Medical Device Requirements (EU MDR 2021); Medical Electrical Equipment (EN 60601)
• Proven experience with wearable injector device filing and maintaining design history files/technical file.
• Strong analytical and problem-solving skills, with the ability to think creatively and innovatively.
• Excellent communication and interpersonal skills, with the ability to work effectively in a multidisciplinary team environment.