Design Quality Engineer

Job Title

Design Quality Engineer

Job Description

Design Quality Engineer (Reedsville, PA or Cambridge, MA)

As part of the global quality and regulatory team supporting Ultrasound, the Design Quality Engineer is an integral part of the product development process and responsible for implementing the Quality Management System through project support. This role is accountable for oversight of system and hardware quality and risk management throughout the product life cycle.

Your role:

• Provide independent oversight of the design input process, design verification and validation activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.

• Provide effective execution of the Design Control and Risk Management processes, including new product introduction and product sustaining activities throughout the product lifecycle. These activities include collaborative partnership with Engineering, Regulatory Affairs, Medical Safety, and other cross-functions to deliver a cohesive and comprehensive solution.

• Lead quality related problem solving and root cause analysis during design and manufacturing.

• Perform risk assessments to evaluate the effects of product defects on residual risk in the field, assessing risk acceptability per company safety risk acceptability policy by using data from internal and external sources and presenting the findings to the management team for review and approval.

You're the right fit if:

• You've acquired 2+ years of experience in design and development of medical devices, root cause investigation, risk management, experience with relevant standards (21CFR820, ISO 13485, ISO 14971), six sigma, statistical analysis, technical writing.

• You have prior experience in a regulated industry, preferred.

• You have a bachelor's degree in Engineering, life 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 position.

• You're a collaborator that thrives as an action-oriented team member to drive solutions. You're not afraid to cross boundaries and support cross-functions, and are a strong communicator.

About Philips

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 our business.

• Discover our rich and exciting history.

• Learn more about our purpose.

• Read more about our employee benefits.

If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

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.

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.