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 project plan and quality plans are made that include all stages of the product s lifecycle targets and strategy for a robust software products development Validates key design inputs including requirements specifications useability reliability performance supportability manufacturability localizability safety security privacy serviceability sustainability and costs Provides effective oversight during the execution of the Quality Plan and any risk management activities and of all design related activities during the lifecycle Contribute during design and development to identify critical quality attributes CTQ CTS and ensure that appropriate mitigations and design controls are applied to mitigate the risks Facilitate design failure mode and effect analysis to identify failure modes early in the design and development process and apply design manufacturing and inspections to mitigate the risks Ensure with objective V V evidences that design output meets the design input Leading quality related problem solving with the cross functional 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 Act as a single point of contact person assigned to for project team s you re responsible to ensure the product s 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 Effective oversight of project deliverables and provide quality input including safety efficacy regulatory Facilitate the product defect investigations and actions during defect management review meetings Participate in audits and regulatory inspection as design quality SME and guide other cross-functional stakeholders on technical aspects and audit conduct 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 self-motivated and skilled individual who continuously strives for excellence as a way of life not just as a job We re 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 that Philips improves every year Specific skill requirements for this role include Bachelor s engineering degree with 12 years Master s degree with 10 years of experience in Software Engineering quality engineering SW Quality- or Reliability Engineering role in the medical or aerospace industry Software testing experience will be an added advantage 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 Well conversant with statistical data analysis regression modeling reliability growth assessment and other quality techniques 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 Effective interpersonal written and oral communication skills expected Ability and willingness to work onsite 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 Learn more about our business Discover our rich and exciting history Learn more about our purpose How we work at Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers We are embracing an approach wherein we spend more time together than apart Our commitment to inclusion and diversity At Philips we provide equal opportunities to all our employees and to all eligible applicants for employment in our company irrespective of age color disability nationality race religion gender sexual orientation LGBTQ and all aspects that make individuals unique Encouraging diversity and fostering inclusion are key to our mission of improving the lives of 2 5 billion people a year by 2030 through meaningful innovation We have fair transparent and transparent employee policies which promote diversity and equality in accordance with currently applicable law For we believe that life is better when youareyou Our hybrid working model is defined in 3 ways We believe in the importance of impactful collaboration There s a certain energy when everyone s in the same room that can heighten idea generation and creative friction needed for problem-solving We embrace flexibility Choosing where when and how to work can vary according to task and team schedules Flexibility isn t office or online it means choosing the space that works best for you your teams and our customers on a case-by-case basis We want to be at our best The way we work and our workspaces are designed to support our well-being offer career advancement opportunities and enable us to be at our best 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