StaffDesignQualityEngineer

## **Role: Staff Design Quality Engineer** ## **Location: Kharadi, Pune** ## ## **Life Unlimited.** At Smith+Nephew, we design and manufacture technology that takes the limits off living. At Smith+Nephew, as Staff Design Quality Engineer would be reporting into the Quality Department, this role has responsibility for supporting Smith and Nephew QMS and new product development activities for Arthroscopic Enabling Technologies and ENT products as a lead Design Quality Engineer. Technological areas of focus for this position include determining methods, techniques, and evaluation criteria for medical devices containing embedded Software, specifically High Frequency surgical equipment. The Design Quality Engineer will support the completion of Design Control and Risk Management requirements and help to ensure that the finished devices will be safe and effective and conform to applicable regulatory requirements. **What will you be doing?** * **(50%) -** Provide quality leadership to new product development project (PDP) and/or sustaining project teams as the Quality Engineering representative on projects requiring FDA 510k, CE Mark, and international regulatory approval. Lead efforts to develop verification and validation test methods and procedures to ensure that the appropriate tests are conducted to assure that embedded software, analog and digital electronic circuits, and support hardware used within instrument products meet the required specifications/standards and that the safety and reliability of products are established. Generate/approve/manage software and design verifications, design validations, usability / human factors, reliability testing, process validations, supplier qualifications, test methods, capability studies, and risk management documentation to support the product DHF. Interface with R&D and manufacturing engineers to identify and resolve defects and product quality issues. Lead project cross-functional communication of status and deliverables to