Philips Design Assurance Engineer 

United States, Minnesota 

701435222

Design Assurance Engineer

Your role:

• Drive Quality norms associated with design engineering projects and lead Quality Plan initiatives associated with Risk Management and Quality System integration.
• Support integration of Risk Management processes throughout the product lifecycle from initial development through post market surveillance in accordance with Philips processes and global standards’ support integration of post market surveillance processes into Design Controls and Sustaining initiatives through analysis of field performance, identification of trends and risks, and actions to eliminate or mitigate adverse post market issues.
• Support the Regulatory Affairs department for submissions and respond to submission questions and support internal and external audits
• Lead and support Corrective and Preventive Actions (CAPA) and QMS continuous improvement initiatives.
• Analyze situations/data using engineering principles and collaboration to identify gaps between project work and QMS; quality responsibility for transfer of new products and sustaining projects to manufacturing and operations quality and supplier quality teams.

You're the right fit if:

• You’ve acquired 1+ years of experience in Quality Assurance, Design Engineering, Systems Engineering, or similar in a highly regulated industry

• Your skills include experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 standards, strong statistical background in verification, validation, hypothesis testing, sampling, multi-factor analyses and measurement system analysis, understanding of design quality tools, methods and activities, demonstrated expertise in managing complex projects and implementing cultural change, proven track record of completing projects on-time that meet all objectives

• You have a Bachelor of Science in Engineering, Sciences or a related field

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

• You have excellent customer service and interpersonal communication skills, experience leading presentations in front of peers and leadership; hands-on problem solver that drives solutions within teams; teamwork skills including influencing and building rapport with internal customers and stakeholders.

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 $59,535 to $102,060.

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.