Pune, IND
13 hours ago
R&D Engineer - Cleaning & Disinfection
Philips is a global health technology leader, focused on improving lives through meaningful innovation. Within our **Connected Care** business, we deliver solutions that connect patients and providers for better outcomes and experiences. This role belongs to **Sleep & Respiratory Care (SRC)** , which provides therapies and technologies for sleep apnea and respiratory conditions. SRC helps patients manage chronic conditions and avoid hospital readmissions, improving quality of life worldwide. The position is based in **Pune** , a center for innovation and collaboration. The Cleaning & Disinfection (C&D) Engineer will support the development and validation of cleaning and disinfection processes by applying technical knowledge of reprocessing, materials compatibility, and regulatory requirements. This role partners closely with R&D and cross-functional teams to help ensure the safety and effectiveness of Sleep & Respiratory Care (S&RC) products throughout their lifecycle. **Your role:** + Supporting the development, evaluation, and validation of cleaning and disinfection processes for reusable medical devices, ensuring all requirements are clear, risk-based, and testable. Executing hands-on and simulated use testing both independently and in collaboration with internal teams and external laboratories. + Authoring, reviewing, and maintaining test protocols, reports, and validation documentation in compliance with FDA, ISO, and global regulatory standards. Working closely with Technical Writers to ensure Instructions for Use (IFU) and labeling accurately reflect validated processes. + Evaluating material compatibility and durability impacts from repeated cleaning and disinfection and assist with accelerated aging and use-life studies to assess long-term device performance. Participating in technical and design reviews to ensure cleaning and disinfection strategies are robust and aligned with product requirements. + Investigating cleaning or disinfection-related issues, contribute to root cause analysis, and support corrective and preventive action (CAPA) activities. Collaborating with product development, risk management, toxicology, usability, and regulatory partners to drive aligned execution and continuous improvement. + Managing assigned project tasks, providing regular status updates to stakeholders, and adhere to internal quality system requirements, including procedures, work instructions, and applicable standards. Ensuring all activities support the delivery of safe, effective, and compliant medical devices. **You're the right fit if:** + You’ve acquired 3+ years of experience in cleaning and disinfection, reprocessing, sterilization sciences, materials compatibility (or similar), within medical device development (preferred). + Your skills include: + Experience executing or supporting cleaning and/or disinfection validation testing (preferred). + Working knowledge of root cause analysis and participation in failure investigations and CAPA activities (preferred) + Familiarity with applicable standards and regulations such as ISO 17664, ISO 10993 (as applicable), FDA reprocessing guidance, and EU MDR (preferred). + You have a bachelor’s degree in Engineering (highly preferred) or a comparable discipline such as Bioengineering, Materials Science, Chemistry or similar. + You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. + You’re an excellent communicator, both written and verbal, and have strong practices in documentation. **How we work together** We believe that we are better together than apart. This is an office-based role, meaning working in person at least 3 days per week. **About Philips** We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. * Learn more about our business. * Discover our rich and exciting history. * Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here. **\#ConnectedCare** **\#LI-EU** **\#LI-Hybrid**
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