Job TitleDesign Quality Engineer - Products & Systems

Job Description

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

Your role:

Ensuring that appropriate Quality plans include all stages of the product’s lifecycle and support Quality Plan designValidating key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability and costsProviding effective oversight on the execution of the Quality Plan, risk management activities and all design related activities during the lifecycleLeading quality problem solvingDrive Design for Reliability and Design for Six SigmaActing as a single point of contact in project teams for End2End Design QualityEnsure the voice of the customer is represented in project teamsUsing post-market data for analytics and statistics to report on the product’s performance in the market (provide feedback to manufacturing, suppliers, or design teams) and initiate field actions when requiredEnsuring the product’s design quality related requirements/criteria are complete and meet the Quality standards for every project milestoneMaking substantial contribution to integrate reliability engineering activities with the medical device development activities

You are a part of

The global Patient Safety and Quality organization.

Within the IGT-System (Image Guided Therapy) department, you'll be part of the Design Quality team.

We constantly strive for further product quality improvements, in a relentless pursuit to improve the quality of life for the billions of people the Philips brand touches every year.

You are a fit if:

Engineering degreeExperience in Quality- or Reliability Engineering in the medical or aerospace industryAbility to define detailed Quality and Reliability plans for new medical product developments to ensure those are Safe, Effective and ReliableAbility to contribute to Risk Management and lead FMEA activities for new products and assurance that control measures are translated in appropriate (critical) requirementsStrong exposure to application of Design Controls; ability to do thorough Design Reviews during new product development to ensure robust designs that further improve patient safety and product qualityAbility to partner with V&V teams to assure thorough Verification, Validation and Usability testingAnalyze development and field data for trends of Product Safety, Quality and Reliability performances and areas for further improvements of Product design and related development processesAbility to conduct reliability analysis to assess the risks associated with design conceptsPerform statistical data analysis, regression modeling, reliability growth assessment and reliability predictionExperience with adequate and accurate review of DHF and DMR documentsUnderstanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304 and ISO 14971Experience with working in multidisciplinary teams in a high-tech R&D environmentYou continuously strive for excellence as a way of life and can inspire others to adopt this mentality of prioritizing quality above all elseYou are a self-starter who embraces the change

In return, we offer you
The opportunity to play a key role in our Patient Safety and Quality transformation journey.

The chance to make an impact in supporting the strategic imperative to raise the bar on quality and bringing our innovations faster to the customers.

Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

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