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Philips Sr Design Quality Engineer Risk Management Germany, Hesse 490245413
In this role, you have the opportunity to raise the bar on the continuous improvement of patient safety and product quality. You leverage your expertise to help build key business design capabilities in. Additionally, you will liaise with project team(s) that develop, qualify and commercialize innovative, life changing medical devices and associated software. These projects can cover every phase of the product life cycle, from development, manufacturing, market deployment, operation and maintenance to phase out.
Your role:
Driving, coaching, supporting and training (or leading in workshops) the use of Risk Management, FMEA and CTS/CTQ flow down best practices and relevant techniques that assure identification and End-2-End (E2E) control of safety and quality product characteristics. Relevant techniques may include not just FMEA, but also for example in fault tree analysis, event tree analysis or preliminary hazard analysis. This includes acting as a go-to subject matter expert for project team(s), business functions and design quality engineers in our team(s); and facilitating FMEA as well as building a community of FMEA facilitators.
Assuring the content quality of FMEAs; e.g. the quality of the input requirements, FMEA preparation, objective ranking, description and traceability of (prevention) controls, …
Is responsible for appropriate and actionable quality plans (as part of Project Management Plan and/or separate) that include all phases of the project and provides effective insight and oversight of the execution of the Quality Plan(s), Risk Management activities, in accordance with QMS processes. You leverage your expertise to actively contribute (or lead) the creations and execution of plans concerning FMEA, CTS/CTQ and/or Risk Management for NPI/MLD projects.
Data validation or actively supporting the data input creation of CTS/CTQ decisions.
Ensuring correctness and completeness of requirements and test evidence traceability through the V-model, with specific emphasis on CTQs and CTSs.
Developing and maintaining your knowledge and expertise resulting in state-of-the-art approaches to structured, data-driven Risk Management, FMEA and CTS/CTQ strategies that increase E2E confidence and reliability of the safety and quality characteristics of our products. This includes acting as a go-to subject matter expert for project team(s), business functions and design quality engineers in our team(s).
(Co-)owning the guidance for CTS/CTQ and (will help to) deploy best practices throughout the business by providing training, coaching and support to relevant functions.
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.
Effective utilization of post-market data analytics on the product’s field performance to continuously improve on Patient Safety and product quality and reliability.
Validates key design inputs like useability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability, and costs. This includes leading the target setting for Quality and Reliability aspects.
Ensures patient/consumer safety & quality in Design Reviews, FMEA and Safety Risk Management, including CTS/CTQ attribute usage, and Verification & Validation with appropriate statistical confidence and reliability.
You're the right fit if:
We are looking for a leader by example with deep understanding of (safety) risk management methodologies including a.o. FMEA and CTS/CTQ flow down; and a proven track record in identifying and assuring E2E control of product safety and quality characteristics of complex medical systems.
PhD or Masters (MSc) degree in Physics, electrical, Mechanical or Industrial Engineering with 7+ years of relevant experience; preferably in Quality- or Reliability Engineering role in the medical or aerospace industry.
Expert knowledge and demonstrable experience with FTA, FMEA, Safety Risk Management (ISO 14971) and Critical to Safety (CtS) / Critical to Quality (CtQ) flow down techniques in complex products to identify critical and important product characteristics so that control over these aspects is assured during all stages of the product’s lifecycle.
You have a DfSS Black belt certification.
Advanced level knowledge of IEC60601, IEC62366 and ISO14971 has a strong preference.
Ability to define detailed Quality and Reliability plans for new medical product developments to ensure those are Safe, Effective and Reliable.
Ability to combine analytical and architectural thinking, physical insight, flexibility and a hands-on mentality to deliver sustainable results and creative solutions.
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.
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
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.
A critical but constructive reviewer
Customer focused, have excellent communication skills and you are a team player.
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.
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