Responsibilities:1.Draft, coordinate and maintain Customer owned Design History File (DHF) strategy and deliverables;2.Be responsible for drafting and maintaining the design control procedures and supporting documentation in the Phillips Medisize Quality Management System;3.Represent Phillips as the subject matter expert in design control regulations and standards during internal and external customer activities, audits and certification activities;4.Write, edit and maintain design quality plans, protocols and reports;5.Work closely with design and development team in identifying and developing User and Stakeholder needs;6.Participate in writing and maintaining user needs and design input requirements;7.Review and approve plans, protocols and reports for testing, verification, validation;8.Develop statistical sampling plans for design and development tasks including verification and validation;9.Execute the test method development and validation efforts including identification of applicable standards and guidance, establishing criteria and approving results;10.Take responsibility for the Risk Management Process, including integration into the design and development process and management of the risk management file;11.Write, edit and maintain risk management plans/ reports and risk assessments including use of risk analysis tools (FMEA, FTA and Hazard Analyses);12.Lead root cause analysis investigations into potential design failures or prospective design changes;13.Interface and support work as a liaison to the Quality Engineer (QE) in design changes, design transfer, design for manufacturing (DFM) and process development.

• Executed design development activities on container components (geometry/material/process) by conducting appropriate studies & data analysis, editing technical documentation, supervising samples preparation & related test campaigns execution.• In the design process, perform risk management and DFEMA with other colleagues. Support process team to complete PFEMA.• Support RA team to complete medical device products (catheter, PD transfer set etc.) registration affairs, and provide technical support.• Designed user friendly products at low production cost and in accordance with manufacturing, marketing, customer expectations and applicable regulator rules.• Supported to engineering activities related to component design (system requirements definition, concept selection & prototyping, product/system interface, functional performance evaluation, design space definition, specifications/BoM/drawings creation & issuance, specific test method development, verification studies, design transfer).• Organized and coordinated activities (TMT/TMV Global –R&D -Palnt) involving other project stakeholders (different functions, different sites) to respect overall project schedule. • Developed new methods for verification/qualification of container closures system. Supported NGC/FINA III project TMV/TMT of container physical test, designed related small tool.• Purchased common equipment and participated to the redaction of the validation documents for laboratory equipment.• Maintained EHS, 6S, quality related activities and other daily operation in container lab. • Supported other activities in container lab, such as Lab Tour, CFDA onsite audit, and Internal/External Audit.

• Support functional tests of container and other activities as needed, lead some testing as needed.• Develop new physical methods of material, semi-product and final product.• Purchase common equipment/Small Tools/ Lab Consumable.• Drive equipment maintenance and calibration consistency and compliance.• Write study protocols/reports, instrument qualification documents, SOPs, memos.• Maintain EHS, 6S, quality related activities and other daily operation in container lab. • Support other activities in container lab, such as Lab Tour, Internal Audit.