In this role you will have the opportunity to assess and test the requirements of patient interface devices. Additional responsibilities of assessing and testing materials to ISO 10993 and ISO 18562, and assessing and testing cleaning and disinfection (C&D) methods of medical devices for compliance to International Standards and FDA Guidance.
You are responsible for
- Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms).
- Develop V&V test plans, test procedures, and test reports.
- Review requirements and scrutinize for testability.
- Quickly learn to use automated test tools and specialty test equipment; develop and validate automated test scripts.
- Execute test procedures both personally and using test technicians.
- Log defects and issues found during V&V activities and track to closure.
- Perform regression analysis and determine testing associated with design changes.
- Provide weekly project status reports.
- Prioritize project tasks to complete on schedule while maintaining quality of work.
- Work in a team environment; peer review work.
- Work on multiple, concurrent projects.
- Document biological test strategies and manage testing with outside test labs.
- Work with a team to assess new or changed C&D methods for products
- Identify/generate validation test protocols
- Hold formal technical reviews to determine methods, sample sizes, inoculation points, treatment cycle counts
- Prepare test sample sets for external labs (validation testing) and internal labs (performance testing)
- Monitor test progress to provide status updates during project meetings
- Generate test reports
- Manage C&D testing with outside test labs.
- Get quotations
- Write POs
- Prepare samples for testing
- Approve C&D protocols
You are part of
This position resides in the Sleep & Respiratory Care Business Group, a business group of Philips HealthTech.
Our vision is to work hand-in-hand with our clinical and consumer customers to transform the personalized healthcare market to meet the significant demands caused by the increase of chronic conditions and an aging society. Our mission is to improve the quality of life for consumers and patients through better awareness, diagnosis, treatment, monitoring, and management of their conditions.
Skills and experience
- Bachelor's Degree in an engineering discipline; mechanical engineering, materials science, or equivalent background.
- 5 years professional experience.
- Knowledge of biological test methods, assessments, and reporting to support FDA submittals.
- FDA 2016 Guidance Document "Use of International Standard ISO 10993-1."
- FDA Guidance for Industry and FDA Staff, March 17, 2015 - Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
- CDC HICPAC Guideline, 2008 - Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
- AAMI TIR12:2010 - Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities, A Guide for Device Manufacturers
- AAMI TIR30:2011 - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
- ISO 10993-1:2009 - Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing.
- ISO 10993-5:2009 - Biological Evaluation of Medical Devices, Part 5: Test for in vitro cytotoxicity.
- ISO 10993-12:2012 - Biological Evaluation of Medical Devices, Part 12: Sample Preparation and Reference Materials.
- ISO 14698-1:2003 - Cleanrooms and Associated Controlled Environments, Part 1: Bio contamination Control - General Principles and Methods
- ISO 15883-1:2014 - Washer-disinfectors, General Requirements, terms and definitions and tests.
- Spectaris Guidelines
We offer you
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what's next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
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