Job TitleDesign Quality Engineer
In this role, you have the opportunity to guide and support multidisciplinary teams to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
You are responsible for
developing and implementing systems to ensure products or services are designed and produced to meet or exceed customer requirements and expectations. You will participate in the change management process to assure the products or services continue to meet customer requirements. You will work with cross-functional teams with other business and engineering disciplines in order to establish the principles of product and service quality evaluation and control for the system. You provide independent oversight and review of the project deliverables throughout the product lifecycle. Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our Health Tech – focused company, you will be responsible to drive product quality improvement activities, using statistics and data analysis techniques to improve product development processes.
Being a member of the R&D teams (e.g. the development team in a product development project) and ensuring that new designs meet quality and compliance standards for every milestone and reviews project and product documentation.
Defining and executing a fast quality feedback plan that supports risk management activities and design quality related activities during all stages of the product/system lifecycle (as independent role in Q&R whilst closely working together with R&D teams).
Validating key design inputs like: Usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
Performing independent technical assessments on product quality performance and leads quality related problem solving and root cause analysis during design.
Performing independent assessments (internal audits) of the way-of-working or product quality.
You are a part of
a fast growing and innovative team, within an ever-changing environment - constantly striving for improvements and exceeding 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’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 billions for the billions of people Philips brand touches each year.
Specific skill requirements for this role include:
Bachelor’s Degree in mechanical or electrical engineering or equivalent demonstrated strong technical competence.
Minimum of 10 years of experience in a medical device (preference), aerospace, automotive or other regulated industry.
Experience with working in multidisciplinary teams in a high tech R&D environment.
Experience with adequate and accurate review of DHF and DMR documents.
Design experience (product quality, reliability engineering) and capability to represent the QA/QE Development team in project teams on product quality and reliability engineering aspects in close cooperation with experts in these fields.
Understanding of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, MDD/MDR and ISO 14971.
Required knowledge of Risk Management / DFMEA / APQP / DFQ / Design Transfer / Design for Manufacturing (DfM) / Lean Methodologies / 5-Why / Problem Solving techniques.
Have an understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up. Experience as auditor/facilitator is an advantage.
In return, we offer you
A rewarding career in Philips with attractive package.
Extensive set of tools to drive your career, such as a personal development budget, training and coaching
Attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
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 2.5 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. Learn more by watching this video.
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.