Design Quality Engineer

Danta Technologies

United States

United States

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Employment Eligibility Statement Due to specific project and client requirements, this position is open to U.S. Citizens and U.S. Lawful Permanent Residents (Green Card holders). Sponsorship is not available at this time. Danta Technologies evaluates all candidates in compliance with the Immigration and Nationality Act (INA) and EEOC guidelines. All hiring decisions are made without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic. One of our Medical devices and health care customer is looking for a senior, onsite Design Quality Engineer who owns design controls, risk management, and regulatory submissions for new product development and design changes in medical devices. 6+ years of Medical devices - Design Quality experience for the projects related to Design Change, Clinical and New Product Development. Good experience in Medical devices regulations – ISO13485, FDA & EU MDR regulations Experience in compiling Design history files & Technical file submission for 510k & CE mark Own Risk Management files – Risk management plan, Hazard Analysis, DFMEA, UFMEA, Risk Management report Work with cross functional teams to execute and/or support various areas of Design Control processes, such as Design Input requirements, Design Outputs, Design Verification and Design Validation. Review & approve all the design history files with cross functional teams (including software deliverables) Support product development equipment qualification activities, test method development and validation activities. Strong in Medical devices technical documentation Excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization. Strong analytical/problem solving, critical thinking, and presentation skills.

United States

Sprachkenntnisse

English

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