Analista de Validação de Reprocessamento

Descrição

Summary: This role focuses on ensuring biological safety and performance of medical devices by leading product reprocessing validation and material compatibility testing, collaborating with various teams, and ensuring regulatory compliance. Highlights: 1. Opportunity to make life better through medical device safety 2. Key role in ensuring biological safety of patient monitoring products 3. Collaborate with R&D, product management, and clinical R&D teams ### **Job Title** Analista de Validação de Reprocessamento ### **Job Description** ***n this role, you have the opportunity to make life better:*** As a Reprocessing Validation Analyst, you will play a key role in ensuring the biological safety and performance of Philips Hospital Patient Monitoring products by leading product reprocessing validation and material compatibility testing. ***You are responsible for:*** * Develop and validate reprocessing methods for reusable medical devices in compliance with ISO 17664 Series. * Support the creation and maintenance of safe and effective reprocessing Instructions for Use (IFU) in collaboration with R\&D, product management, clinical R\&D, usability engineering, and learning product functions. * Assess and manage the impact of manufacturing, supplier, and material changes on patient\-monitoring medical devices and accessories. Ensure reprocessing efficacy and material compatibility for both existing and new products. * Perform risk assessments, evaluations, and testing related to reprocessing efficacy and material compatibility, and provide detailed reports. * Support complaint investigations, CAPAs, and general technical support inquiries related to reprocessing. * Prepare technical reviews, specifications, and documentation for regulatory submissions, assisting in responses to global regulatory authorities. * Ensure that testing meets all international and domestic regulatory requirements, including ISO, FDA, EU MDR, GLP, Japan, and APAC regulations. * Collaborate and clearly communicate with internal and external stakeholders to ensure proper planning and execution of reprocessing validation and material compatibility testing. ***You are a part of:*** The Biosafety and CDE team belongs to the global Hardware Test Engineering organization within the Hospital Patient Monitoring business. You have a direct reporting line to the Biosafety and CDE Leader located in the US. ***You're the right fit if:*** * You have a minimum of a Bachelor’s degree in Material Engineering, Chemical Engineering, Chemistry, Mechanical Engineering, Microbiology, or Biomedical Engineering (Master’s or PhD preferred). * You’ve acquired a minimum of 2 years of experience in reprocessing verification \& validation. Experience in material/chemical compatibility and microbiological test methods for compliance with ISO 17664 is a plus. * You have a working understanding of global medical device regulations/requirements/standards and experience working with Contract Resource Organizations (CRO’s) to generate test plans/evaluate results for compliance with pertinent standards, i.e., reprocessing standards (ISO 17664, AAMI TIR12, ST98, ISO 17665, and ISO 11135\) and the US FDA’s Reprocessing Guidance. * You can provide effective project management and communication skills in a dynamic, matrixed, geographically diverse business environment to meet deadlines and deliver on commitments. * You are effective at accurately scoping projects, considering the full impact of decisions and actions taken, and balancing multiple priorities and project deliverables. * A detailed understanding of the product development process is preferred. * Strong verbal and written communication skills in English with the ability to communicate effectively at multiple levels of the organization. * You are proficient in statistics and the Microsoft suite of office applications. * Ability to travel approximately 10%, potentially internationally. **How we work together** We believe that we are better together than apart. For our office\-based teams, this means working in\-person at least 3 days per week. This role is an office role. **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 .