Philips Electro-Mechanical Medical Device Design Quality Engineer 

United States, New York, New York 

756677667

Electro-Mechanical Medical Device Design Quality Engineer
Job Description

The Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes

Your role:

• Independently produces quality engineering documents, coordinates quality plan design for hardware/software and system design, and supports stakeholders during the execution of quality system, product audits, and inspections.

• Executes assessment of product and system designs, reviews of test and other performance data, analysis of market feedback, carrying root cause analysis, quality problem solving, and addressing quality engineering deficiencies to embed quality in design.

• Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.

• Provides effective oversight of execution of quality, reliability, PMS Plans, Risk Management activities, and all design related activities during the product/system lifecycle including deliverables created by otherto assure product and process compliance.

• Maintains a working knowledge of generic products/services and Quality Engineering techniques, addresses problems of diverse scope, requiring the evaluation of identifiable factors, demonstrating sound judgment in selecting methods for obtaining solutions, and frequently interacts with supervisors and functional peer groups to gain cooperation of others.

• Acts as an advisor to subordinate(s) and cross-functional partners, providing guidance to meet schedules and/or resolve technical problems effectively, develops schedules and performance requirements, and may have budget responsibilities.

• Cultivates effective relationships, shares knowledge, provides influence over projects and peer groups, demonstrating full understanding of area of specialization, and possesses working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, and ISO 9001.

• Establishes and improves Quality & Regulatory (Q&R) capabilities supporting customer services business and leads in design and deployment of customer service strategy and solutions which exceed customer expectations.

• Independently produces CAPA records and performs timely Corrective and Preventive Action (CAPA) engineering tasks, including assessment of issue descriptions and reviewing CAPA data sources.

You're the right fit if:

• Education: Bachelor's Degree/ Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.

• Experience: 7+ years of experience with Bachelor's or 5 years of experience with Master's in areas such as Quality Engineering, Safety Engineering, Process Engineering or equivalent.

• Certifications: ASQ CQE or CQM . 13485 auditor.
• High-level English language proficiency including strong writing skills

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

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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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 .

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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.