Job Title: Design Quality Engineer I Duration: 1+ Year Contract

Job Description

We are seeking a detail-oriented and proactive Design Quality Engineer I to join our team in Irvine, CA. This position plays a critical role in supporting new product development (NPD) activities by ensuring design control processes are robust, compliant, and well-documented. The ideal candidate will work cross-functionally with engineering, manufacturing, regulatory, and operations teams to ensure product quality and regulatory readiness throughout the product development lifecycle.

Key Responsibilities Develop and maintain quality assurance documentation for new product development and regulatory submissions. Ensure compliance by identifying and correcting deficiencies in design control procedures and practices. Participate in cross-functional design, development, manufacturing, and risk management activities . Define design verification and validation (V&V) test requirements and prepare statistically valid test protocols and reports. Support Advanced Operations in the development of manufacturing processes for new products. Apply risk analysis tools (e.g., FMEA) to define critical quality attributes and track mitigation activities. Assist in design reviews , evaluating quality-related risks and ensuring corrective actions are implemented. Review and approve inspection plans, engineering drawings, routers, and manufacturing documentation. Support design transfer activities to ensure smooth transition from R&D to production. Evaluate predicate devices and historical quality data to inform product development strategy. Lead and document risk management activities, including plans and reviews. Monitor and collect early field performance and customer feedback for continuous improvement. Required Qualifications Bachelor's degree in Engineering or related field. 2-5 years of experience in medical device product development . Solid understanding of Design Control , Risk Management , and Design/Process V&V in a regulated environment. Hands-on experience with Advanced Quality tools : FMEA, Root Cause Analysis, Mistake Proofing (Poke Yoke), and GD&T. Familiarity with FDA, ISO 13485 , and international medical device regulations. Ability to read and interpret CAD drawings . Strong communication, project management, and interpersonal skills. Proficiency with statistical tools such as Minitab or equivalent. Preferred Skills Experience interacting with regulatory agencies (FDA, TUV, MoH). Background in CAPA , audit readiness , and compliance risk evaluation. Ability to thrive in a matrixed environment and work independently with minimal supervision. Strong analytical and problem-solving mindset.