Philips Software Design Quality Engineer 

Germany, Hesse 

314649064

Software Design Quality Engineer

Your role

• Ensure that appropriate SW Quality plans are designed that include all stages of the software lifecycle
• Validate key product design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability and costs
• Provide effective oversight over the execution of the SW Quality Plan; which includes risk management activities and all design related activities during the software lifecycle
• Ensure software design quality and reliability targets are met for every project milestone
• Leading software quality related problem solving
• Using post-market data analysis to report on software performance in the market (provide feedback to manufacturing, suppliers or design teams) and initiate field actions when required
• Act as a single point of contact for project team
• Make substantial contribution to ways of working of combining Agile with medical software development

You are a part of

The global Patient Safety and Quality organization.

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

You're the right fit if

• Engineering degree
• Working experience in Software Engineering, Software Quality or Reliability Engineering
• Familiar with the medical or the aerospace industry
• Ability to define detailed software 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
• Ability to lead reliability analysis to assess the risks associated with design concepts
• 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

• 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 the lives of others.
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