SW Product Quality & Regulatory Leader

Job Description

You are responsible for

• Ensure that appropriate SW Quality plans are designed that include all stages of the software lifecycle.
• Validate key product design inputs like useability, 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 (person assigned to) for project team(s);
• Make substantial contribution to ways of working of combining Agile with medical software development.

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 of MR 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
Specific skill requirements for this role include:
 

• Bachelor’s engineering degree with 15+ years of experience / Master’s degree with 13 years of experience; preferably in Software- or Reliability Engineering role in the medical or aerospace industry.
• Ability to define detailed SW Quality and Reliability plans for new SW product development to ensure SW products are Safe, Effective and Reliable.
• Ability to perform SW Risk Management and SW Design FMEAs with teams on all new products and recommend design changes to improve product safety and product quality; and subsequent 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 robustness of SW product design.
• Ability to partner with V&V teams to assure thorough SW Verification, Validation and Useability 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.
• Certified DfSS greenbelt or blackbelt.
• 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.

About Philips
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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• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.