Senior Product Quality Engineer

Job Title

Job Description

You will be supporting the Business Unit Magnetic Resonance Imaging (MRI) within Philips Healthcare. We are passionate about serving our customers and making a meaningful contribution to (product) quality. You will work in cross-functional project (core) teams consisting of, amongst others, R&D, Service, and Industrialization. In addition, you will have the ability to interact across different sites as a benefit of being part of a global organization.

Your role:

• Independent oversight of product performance as this relates to Product Quality, Safety and Reliability

• During (early) Development and Lifecycle Maintenance: Participate in establishing the quality and reliability strategy specific to the product(s) in scope. Involved in quality target setting in Project Charter

• Contribute to the execution and delivery of results specific to product quality: Review reliability plans , review key quality related requirements , ensure a proper transfer of design specifications  to manufacturing and supply chain and service, perform assessment on the design/architecture on suitability for the quality criteria, and review key product related deliverables (Reliability Reports, Reliability modelling for predictive analysis, FMEA’s, Change Point Analysis, etc.)

• Apply and facilitate data driven Design for Quality & Reliability best practices (FMEAs, robust design, V&V, root cause analysis & problem solving)

• Support and lead quality related problem solving and root cause analysis as they relate to design and development and define and establish best practices

• Provide reliability-engineering services to all Philips internal customers including: Reliability analyses, reliability predictions, reliability testing and test planning, and reliability related problem solving.   

• Coordinate efforts to establish product reliability goals and to plan, execute and monitor activities aimed at achieving those goals.

• Support the group by translating test data into reliability predictions.

• Work with product engineering to develop reliability requirements and decompositions, establish a reliability program and perform appropriate analyses to ensure that new medical products meet all appropriate requirements. 

• (co)Develop a reliability plan that documents tasks, methods, tools, tests and analyses required to ensure products are safe and reliable. 

• Participate in product design reviews during new product development to ensure robustness of product design and manufacturing processes. 
   

You're the right fit if:

• Masters degree in Reliability Engineering, Mechanical, Electrical or Software Engineering with 5+ years’ experience in in a regulated industry (preferably medical) with product reliability of complex electrical/mechanical products.

• Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.)

• Experience or understanding of quality tools, methods and standards (Weibull++, Minitab, reliability modeling, statistical analysis, warranty analysis, HALT, ALT, IEEE1624)

• Experience or understanding of Software or Hardware development, Data mining, Verification and Validation, Artificial Intelligence, Risk management, RCA, Requirements Management, Design, Usability

• Experience or qualification: Design for Six Sigma and Statistics or proven experience in problem solving and root cause analysis tools, Design for Reliability, FMEA, Usability, APQP, Design Form Manufacturing and Test, Meddev awareness, AAMI Design Controls / Risk Management, Program management

• Demonstrated success in leading change for product quality and reliability

• Ability to support development, manufacturing, field data analysis and develop intelligence in estimating current performance and future trends

• Effective interpersonal, written and verbal English communication skills expected.
   

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This role is an office role.

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.

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.

#LI-EU

#LI-hy