Philips Senior Validation Engineer 

United States, Colorado 

624778687

Your role:

• Understanding system functionality, technical requirements, and overall system architecture/integrations in a rapidly evolving software landscape.
• Defining user needs and requirements, and documenting key software functionality during development/configuration.
• Understanding relevant regulation including 21CFR part 11 compliance, key standards (e.g. ISO 15223-1, ISO 15415, ISO 15416, etc.), and defining the impact to needed software functionality and validation.
• Understand the rapidly changing software environment, and identify impacts to the validated state of labeling software.
• Define hardware needs, and conduct thorough testing of all hardware that is validated for use with the labeling software tools.
• Assist operations team with the design and validation of labeling processes throughout the labeling lifecycle.

You're the right fit if:

• Bachelor's Degree in computer science, systems engineering, or equivalent.
• 5+ years of experience in software or system validation in regulated environments.
• Detail oriented, self-motivated, well organized, excellent written and verbal communication, and the ability to take high level goals or requirements and translate them to individual tasks/deliverables.
• Ability to work and communicate with all levels of the organization.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

How we work together

This is an in office role

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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The pay range for this position in Plymouth, MN is $92,000 to $150,000

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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.