Philips Sr Design Quality Engineer Verification & Validation 

Germany, Hesse 

578840528

Sr. Design Quality Engineer (Verification & Validation)Job Description

In this role, you have the opportunity to r. 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:

• 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​.

• Driving, coaching and supporting the use of Requirements Engineering best practices; as well as those best practices to define objective verification, validation and useability evaluation strategies, load cases for verification, correct application of statistical techniques and sampling strategies to assure sufficient confidence in the product/service prior to release to market​. This includes acting as a go-to subject matter expert for project team(s), business functions and design quality engineers in our team(s).

• Validates key design inputs like useability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability, and costs. This includes review and/or support creation of a complete and consistent set of requirements according to all requirements quality criteria (necessary, feasible, unambiguous, verifiable, …); supporting the data collection for requirements definition; taking the lead in or facilitate, as appropriate, requirements elicitation/definition workshops aligned with relevant stakeholders; and leading the target setting for Quality and Reliability aspects.

• Ensuring correctness and completeness of requirements and test evidence traceability through the V-model, with specific emphasis on CTQs and CTSs

• Developing and maintaining the knowledge and expertise resulting in state-of-the-art approaches to structured, data-driven product development, manufacturing and maintenance strategies that increase confidence and reliability of the safety and quality characteristics of our products. You will help to deploy best practices throughout the business by providing training, coaching and support to relevant functions.

• Effective utilization of post-market data analytics on the product’s field performance to continuously improve on Patient Safety and product quality and reliability.

• 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.​

• 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 Design for Six Sigma and the ability to apply that in the End-to-End development of complex (medical) systems (from design to maintenance). You have a proven track record in analyzing complex product issues by application of various data analysis, problem solving / root cause finding techniques. A talented (natural) trainer and coach that is able to explain complex concepts in easy to understand terms, able to catch people's attention.

• 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.

• In-depth knowledge and a proven track record in implementing and applying concepts in the fields requirement engineering and test management; coaching, supporting and training relevant roles (e.g. system architects/designer and lead (test) engineers) to develop SMART, testable requirements, a risk based integration and testing strategies and creating actionable integration and verification plans.

• Strong experience in coaching, supporting and training a System Engineering approach with focus on Design for Quality, Reliability, Serviceability, Testing (DfX) in innovative healthcare projects; as well as other business excellence methodologies like DfSS, DMAIC, Statistical Engineering (Shainin tools), PDCA, Kaizen events, SPC, 8D ...

• 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.

• Combine analytical and architectural thinking, physical insight, flexibility and a hands-on mentality to deliver sustainable results and creative solutions. Identify improvement opportunities in Philips businesses with respect to the Requirements, Test and Verification proposition and develop actionable proposals, plans and tailored training materials or workshops to address these.

• 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 V&V teams to assure thorough Verification, Validation and Useability testing.

• Experience with working with requirements or test management tools, e.g. DOORS, ALM, Integrity, Polarion, …

• 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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