Analista de Validação de Reprocessamento
Job Description
In 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 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 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.
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