Senior Design Quality Engineer

In this role, you have the opportunity to

• Lead on setting Quality and Reliability targets for IGT Systems medical products so that these innovative products deliver high quality and outstanding reliability to the lives they will improve.
• 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.
• Closely work with the post market teams to bring back the learnings from the fielded products (Installed base) and work with the R&D team to implement the design changes to fix the issues to make the products better.

You are responsible for

In partnership with other functions, defining and managing the holistic patient and user safety, quality and reliability strategy and approach, overseeing execution and quality of results, driving to sufficient confidence in the product/service prior to release to market.

• Ensuring that appropriate Quality plans are made that include all stages of the product’s lifecycle and support Quality Plan design.
• Validating key design inputs like usability, reliability, performance, safety, quality and their related test strategies to ensure appropriate statistical confidence and reliability levels.
• Providing effective oversight on the execution  of the Quality Plan and any risk management activities, and of all design related activities during the lifecycle of the product.
• Leading quality related problem solving.
• Ensuring that the post-market data on the product’s performance is effectively used to make required design/process improvements through close collaboration with the cross functional teams.
• Acting as a go-to subject matter expert for project team(s) and business functions to provide guidance on all Design Control processes in the product design and development. You are 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 requirements engineering/CTS/CTQ flow down activities with the medical device development activities.

With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.

Good working conditions.

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

We are looking for a leader, who leads by example, 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 Philips brand touches each year.

Specific skill requirements for this role include:

• Bachelor’s engineering degree with 12+ years of experience / Master’s degree with 8+ years of experience; preferably in Quality or Reliability Engineering role in the medical or aerospace industry.
• Additional R&D background and mindset with knowledge of product and software development processes would be desirable.
• Preferably, you have a DfSS Green Belt certification and are willing to further develop towards Black Belt certification.
• Experience in applying problem solving/root cause finding methodologies
• Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC60601, IEC62366 and ISO14971 would be a plus.
• Ability to define detailed Quality and Reliability plans for new medical product developments to ensure those are Safe, Effective and Reliable.
• Ability to lead Risk Management and FMEA activities for new products and assurance that control measures are translated into 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 Verification & Validation teams to assure thorough 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.
• Strong experience with Systems Engineering methodologies / tools.
• Experience with adequate and accurate review of DHF and DMR documents.
• 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.

Furthermore to be successful in this role you are

Motivated, self-driven with a determination to succeed and the ability to adapt to change.

• Analytical, you are open to new ideas and believe in continuous learning in order to develop new competencies.
• You combine analytical and conceptual thinking, physical insight, flexibility and a hands-on mentality to deliver sustainable results and creative solutions;
• A critical but constructive business partner
• Customer focused, have excellent communication skills and you are a team player.
• Excellent reporting and documentation skills;
•  Excellent consultancy skills and the ability to connect with business stakeholders;
• Good project management skills (sense of urgency)