**Duration: 12 Months Contract** **Job Purpose** + The Design Quality Engineer will support the application of design controls to projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and improvements for manufacturability and cost reduction. This individual will work with a cross-functional team to ensure safety, quality, and compliance of products. + Imaging diagnostic catheter design changes + Working with a team of 5 Design Assurance engineers + Total team of 20 **Key Responsibilities** + Ownership of design change projects including scoping, assessment, and implementation. + Develop, update, and maintain Design History File and Design Input / Output documentation + Develop, update and maintain risk management files, such as the HClientard Analysis, Task Analysis, and Design FMEA. + Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements. + Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs. + Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. **Quality Systems Duties and Responsibilities:** Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. **Qualifications** + Bachelor’s degree in an engineering discipline + Experience in design assurance, quality, or related medical device or regulated industry experience + 5 - 7 Years experience with BS, 3 - 5 Years with MS + Medical device experience preferred + Must have worked in a regulated space + Design quality experience + Design assurance experience + Risk management experience + Good problem-solving ability **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com. US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.