Philips Sr Design Assurance Engineer 

United States, Minnesota 

793703521

Sr. Design Assurance Engineer

Your role:

• Ensure Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Familiarity with ISO 14971, Risk Management for medical devices.
• Knowledge of how to apply Design Controls and Process Controls. Provides critical quality review of design requirement rationales, test methods, training requirements and test method validation requirements.
• Determines and recommends sampling plans, equipment requirements, measurement techniques and training requirements that will assure specific quality levels.
• Experienced in component inspection and testing techniques; must be able to read and interpret blueprints.Works with cross functional team to complete component qualification activities.

You're the right fit if:

• Good understanding of Medical Device QSR, ISO 13485 and ISO 14971.
• Demonstratedexperience working underDesign Controls in phase gate new product development role. Able to analyze, trend and draw conclusion from data.
• 5+ years engineering experience.
• Bachelor's Degree in: Mechanical, Chemical or Bio-medical engineering.
• 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.

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The pay range for this position in Plymouth, MN is $82,000 – $130,000, Annually.

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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.

within commuting distance to Plymouth, MN.