Philips Product Safety & Risk Engineering Expert 

United States, Massachusetts, Cambridge 

353585337

Product Safety & Risk Engineering Expert

Your role:

• Will guide and facilitate safety risk management activities of a cross-functional team of experts, ensuring adherence to process and applicable standards like ISO14971, IEC 62366-1, IEC 82304, and IEC 62304.
• Project responsibility for operational safety risk management activities such as: creation/maintenance of risk management plans/matrices, ensuring completeness/quality of risk controls and traceability between risk management artifacts, requirements, and verification.
• Responsible for the risk management documents in the technical file, as well as post-release risk management activities.
• Reporting to the Safety Risk Engineering Leader, you will collaborate with systems engineers and subject matter experts throughout the product development process.

You're the right fit if:

• You’ve acquired a Minimum of 7 years’ experience in FDA regulated medical device product development, with a focus on product safety, risk management and compliance, for software driven systems/devices.
• Your skills include expertise in Product Safety Risk Engineering as an integrated discipline in the systems engineering workflow, including strong knowledge in Risk Analysis Methodology (e.g., FMEA, FTA, PHA). Knowledge/experience in Software as a Medical Device (SaMD), Model Based Systems Engineering (MBSE), V-Model- desired.
• You have In-depth knowledge of FDA regulations (ISO/IEC/CFR) related to risk management and the development of safe software products including ISO 14971, 21CFR 820, EU MDR, IEC 82304, IEC 62304, and IEC 62366-1
• You have a Minimum of a Bachelor’s Degree in Engineering (Required)-Systems,Computer Science/Engineering,Biomedical Engineering or similar disciplines. Master’s Degree desired.
• 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 Cambridge, MA is $139,000 to $223,000.

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 Cambridge, MA.
• May require travel up to 10%.