Design Quality Engineer

Job Title Design Quality Engineer Job Description Job title: Design Quality Engineer You Role: While positioned within the Business Unit MR, reporting to the Segment OEM & Coils DQE Leader, you will support the Quality, Reliability and Safety of Medical Devices though all lifecycle phases of the medical device. You will contribute to achieve quality objectives as they relate to: Customer Experience, Complaint Rate, and First Past Yield. You will work in an independent Quality & Regulatory organization with key stakeholders during various stages of the design, development and maintenance of the medical device. Representing Design Quality during the execution of new development programs and sustaining activities and interfacing with regulatory affairs 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 Act as a product quality lead by defining the activities in the Product Quality Plan to meet product quality targets 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 Design for Quality & Reliability best practices (FMEAs, robust design, V&V, root cause analysis & problem solving) Regularly go through the history of quality issues (leverage data of post-market analysis like Complaints, Quality Notifications, DeFOA, Defect) and drive improvement through proposals Support and lead quality related problem solving and root cause analysis as they relate to design and development and define and establish best practices Your KAR's Ensures that the Voice of the Patient/Consumer is adequately represented in the project team ensuring patient/consumer safety and quality in decision making, e.g. setting of unambiguous appropriate customer/patient-focused targets (reliability, usability, availability, serviceability, manufacturability)​ Is single point of contact in project teams for end-to-end design quality, collaborating with multiple stakeholders within and outside of quality function, responsible to provide direction on design quality-related matters where needed In partnership with other functions, defines and manages the wholistic patient/consumer 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 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 In partnership with other functions, is responsible for delivery of patient/consumer safety, quality and compliance in key design input traceable to key design output, in accordance with applicable QMS processes Supports and drives the use of focused methodologies, e.g. Design for Reliability, Design for Six Sigma, RCA, etc, to support the quality objectives.  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.​ Assesses patient/consumer safety & quality performance throughout all phases of the project and post-launch product