Senior Design Quality Engineer - Products & Systems

Lead the setting of Quality and Reliability targets for IGT Systems medical products, ensuring high quality and outstanding reliability. Utilize expert Quality and Reliability engineering skills to coach project teams and ensure targets are met. Collaborate with post-market teams to integrate learnings from fielded products and implement design changes for continuous improvement. Define and manage patient and user safety, quality, and reliability strategy, overseeing execution and driving confidence in products before market release. Validate key design inputs and provide oversight on Quality Plan execution and risk management activities.

Must Have

• Define and manage holistic patient and user safety, quality and reliability strategy.
• Ensure appropriate Quality plans are made for all product lifecycle stages.
• Validate key design inputs like usability, reliability, performance, safety, quality.
• Provide effective oversight on Quality Plan execution and risk management activities.
• Lead quality related problem solving.
• Ensure post-market data is used for design/process improvements.
• Act as subject matter expert for Design Control processes.
• Make substantial contribution to integrate requirements engineering/CTS/CTQ flow down activities.
• Bachelor’s engineering degree with 12-14 years of experience / Master’s degree with 12+ years of experience.
• Experience in applying problem solving/root cause finding methodologies.
• Ability to define detailed Quality and Reliability plans.
• Ability to lead Risk Management and FMEA activities.
• Strong exposure to application of Design Controls.
• Ability to do thorough Design Reviews.
• Ability to partner with Verification & Validation teams.
• Analyze development and field data for trends.
• Strong experience with Systems Engineering methodologies / tools.
• Experience with adequate and accurate review of DHF and DMR documents.
• Experience with working in multidisciplinary teams.
• Effective interpersonal, written and oral communication skills.
• Ability and willingness to work at least 3 days in office.

Good to Have

• Additional R&D background and mindset with knowledge of product and software development processes.
• DfSS Green Belt certification and willingness to develop towards Black Belt certification.
• Understanding of global medical device regulations, requirements, and standards (21CFR820, ISO13485, EU MDR, IEC60601, IEC62366, ISO14971).

Perks & Benefits

• 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

Job Title

Senior Design Quality Engineer - Products & Systems

Job Description

Job Title: Design Quality Engineer – Products & Systems

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.

You are a part of

You will be part of the global Philips Patient Safety & Quality organization and will be reporting within the Design Quality team for our IGT-Systems Business. 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 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 12-14 years of experience / Master’s degree with 12+ 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).

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’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum.

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’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

About Us

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.

For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.

Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.

To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

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