Philips Design Quality Engineer 

United States, Colorado, Colorado Springs 

196567937

In this role you

You are responsible for creating and executing comprehensive process validation strategies to ensure new products transition seamlessly to production, adhering to quality and regulatory standards. The role executes the full design control process, including validation and design transfer, and ensures accurate and up-to-date quality engineering documentation.

Your role:

• Creates and executes comprehensive Design Test Method Validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision.
• Handles the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards.
• Keeps a check on the drafting and updating of detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements.
• Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
• Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality.

You're the right fit if:

• Bachelor's Degree/ Master's Degree inMechanical Engineering, Electronics Engineering, Science or equivalent.
• Minimum 2+ years experience in Design Quality Management in Medical Device.
• Prefer 5+ years of experience with Design, Test Validation, Usability, Reliability, Performance, Manufacturability, Safety, Audit, CAPA.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together

This is an 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.

• Learn more about .
• Discover
• Learn more about
• Learn more about

.

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.

will notbe provided for this position. For this position, you must reside in