Job Information
Philips Design Quality Engineer - Products & Systems in Best, Netherlands
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 design
Validating key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability and costs
Providing effective oversight on the execution of the Quality Plan, risk management activities and all design related activities during the lifecycle
Leading quality problem solving
Drive Design for Reliability and Design for Six Sigma
Acting as a single point of contact in project teams for End2End Design Quality
Ensure the voice of the customer is represented in project teams
Using 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 required
Ensuring the product’s design quality related requirements/criteria are complete and meet the Quality standards for every project milestone
Making 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 degree
Experience in Quality- or Reliability Engineering in the medical or aerospace industry
Ability to define detailed Quality and Reliability plans for new medical product developments to ensure those are Safe, Effective and Reliable
Ability to contribute to Risk Management and lead FMEA activities for new products and assurance that control measures are translated in appropriate (critical) requirements
Strong 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 quality
Ability to partner with V&V teams to assure thorough Verification, Validation and Usability testing
Analyze development and field data for trends of Product Safety, Quality and Reliability performances and areas for further improvements of Product design and related development processes
Ability to conduct reliability analysis to assess the risks associated with design concepts
Perform statistical data analysis, regression modeling, reliability growth assessment and reliability prediction
Experience with adequate and accurate review of DHF and DMR documents
Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304 and ISO 14971
Experience with working in multidisciplinary teams in a high-tech R&D environment
You continuously strive for excellence as a way of life and can inspire others to adopt this mentality of prioritizing quality above all else
You 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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