Job Description

Job Title Software Design Quality Engineer



Job Title

Software Design Quality Engineer



In this role, you have the opportunity to

Lead on setting Quality and Reliability targets for IGT Systems medical software so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Next to setting targets, you use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved.

This involves being a confident advisor on quality and reliability engineering topics.

You are responsible for

• Ensure that appropriate Quality plans are made that include all stages of the product\xe2\x80\x99s lifecycle and support Quality Plan design.
• Validates key design inputs like useability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability, and costs.
• Provides effective oversight the execution of the Quality Plan and any risk management activities, and of all design related activities during the lifecycle.
• Leading quality related problem solving
• Using post-market data for analytics and statistics to report on the product\xe2\x80\x99s 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 (person assigned to) for project team(s); you\xe2\x80\x99re responsible to ensure the product\xe2\x80\x99s design quality related requirements/criteria are complete and meet the Quality standards for every project milestone.
• Make substantial contribution to integrate reliability engineering activities with the medical device development activities.

You are a part of

You will be part of the global Philips Q&R organization and will be reporting within the Design Quality team for IGT-Systems. As member of this team, you contribute to our constant strive for further product quality improvements, so we continuously exceed both internal and external stakeholder expectations.

To succeed in this role, you should have the following skills and experience

We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life, not just as a job. We\xe2\x80\x99re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life for the billions of people Philips brand touches each year.

Specific skill requirements for this role include:

• Bachelor\xe2\x80\x99s engineering degree with 15+ years of experience / Master\xe2\x80\x99s degree with 10+ years of experience; preferably in Software Engineering or SW Quality- or Reliability Engineering role in the medical or 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 Useability testing.
• Analyze development and field data for Product Safety, Quality and Reliability performances and areas for further improvements of Product design and related development processes.
• Ability to lead reliability analysis to assess the risks associated with design concepts.
• Define and lead 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.
• Being certified DfSS greenbelt or blackbelt has a preference.
• Experience with working in multidisciplinary teams in a high-tech R&D environment.
• Effective interpersonal, written and oral communication skills expected.
• Ability and willingness to work at least 3 days in office.

In return, we offer you

We welcome you to a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences:

• A market conform salary
• 25 Days of leave and the possibility to purchase up to 20 extra days off annually
• A variable bonus based on both Philips results and personal performance
• Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
• Solid company pension scheme and attractive collective health insurance package
• Opportunity to buy Philips shares and products with discount
• Healthy work-life balance

Why should you join Philips?

Working at Philips is more than a job. It\xe2\x80\x99s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it\xe2\x80\x99s like working for Philips at a personal level, visit the on our career website, where you can read stories from our . Once there, you can also learn about our , or find answers to some of the .

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