Philips Design Quality Engineer - Products & Systems 

Germany, Hesse 

613525309

Design 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 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.

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, regressionmodeling,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
• Youcontinuously 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