Position : Japanese Bilingual Senior Engineer Industry : Medical / Pharmaceutical Classification : Full-Time, Exempt Schedule : Full-time (8 hours a day) with a hybrid work model Work Location : Tustin, CA (Hybrid: 2-3 days per week in-person) Overview : A leading provider of high-quality medical device components is seeking an experienced Senior Engineer. The role requires excellent communication skills in Japanese and English, a strong technical background, and an interest in the medical device industry. You will support sales and product development, contributing technical expertise from understanding customer requirements to project progression from prototype to mass production. Essential Duties and Responsibilities : Collaborate with sales teams and customers to understand needs and define technical requirements. Prepare and maintain engineering documentation such as design specs, test protocols, and reports. Assist in developing account strategies and proposals with insights as a technical expert. Respond to technical inquiries from customers regarding products and services. Join client visits with sales representatives to understand customer needs and present technical solutions. Develop and deliver product presentations and demonstrations highlighting technical capabilities. Prepare detailed responses for Requests for Proposals (RFPs). Stay updated on industry trends by attending trade shows and conferences. Mentor junior engineering staff and sales teams. Coordinate with overseas teams throughout the product lifecycle to ensure seamless project progression. Manage change requests from the quality team, ensuring clear communication and implementation. Handle customer quality issues effectively, ensuring resolution and communication. Implement corrective and preventive actions based on customer feedback. Review quality reports and communicate findings clearly to customers. Work with overseas teams during validation processes, review validation documents, and occasionally work late due to time zone differences. Perform other duties as assigned by management. Qualifications : Bachelor's or Master's in Mechanical Engineering, Biochemical Engineering, or related field. At least 5 years of engineering experience, including documentation skills. Bilingual in Japanese and English (reading, writing, speaking). Willingness and ability to travel domestically and internationally. Preferred Qualifications : Experience in the medical device industry, familiar with regulations like FDA and ISO 13485. Knowledge of medical device finished products and materials such as metals and polymers. #J-18808-Ljbffr Staffmark Group
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