Philips Biocompatibility & Disinfection Engineer 

United States, Pennsylvania, Brown Township 

531094072

Your role:

• Will monitor and interpret standards and regulatory requirements for biocompatibility, cleaning, and disinfection of transducer / Ultrasound devices.
• Maintains awareness of automated cleaning processes and potential impact to transducers / Ultrasound devices.
• Identifies and specifies product compliance testing requirements, ensure appropriate processes are in place and that compliance testing is performed in a timely manner as it relates to biocompatibility, chemical compatibility, and disinfection testing.
• Performs gap assessments of new materials and any requirements to test for biocompatibility or device disinfection changes.
• Addresses customer inquiries as it relates to different disinfection methods, processors, or disinfectants.
• Will collaborate with externallaboratories/institutesin relation to testing needs.

You're the right fit if:

• You’ve acquired a minimum of 3+ years’ experience in Biocompatibility, Chemical and Disinfection testing, with a focus on Biological Risk Assessments/Test methods for compliance within FDA regulated product environments (ISO 13485/10993).
• You have strong knowledge in automated cleaning processes and the potential impact on FDA regulated materials/products (Ultrasound devices/transducers).
• You have a strong understanding of global medical device regulations/requirements/standards (ISO 10993, ISO 13485, 21 CFR Part 803, 806 & 820) and experience working with outside test labs to evaluate results for compliance with biological/Chemical/Disinfection standards.
• You have experience documenting/validating Biological/Chemical/Disinfection test methods (TMV)/processes, analyzing results from Contract Resource Organizations (CRO’s) and communicating with NPD teams and CROs to explain the results of Biological assessments.
• You have a minimum of a Bachelor’s degree in Material Science, Toxicology, Chemical Engineering, or similar disciplines (Required), Master’s Degree desired. Knowledge of FDA 2020 Guidance Document “Use of International Standard ISO 10993-1” (preferred)
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

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 improve the lives of others.

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Philips Transparency Details:

• The pay range for this position in Reedsville, PA is $99,000 to $158,000.

Additional Information

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Reedsville, PA.