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Japanese Bilingual Senior Engineer
- California
- Tustin
- Salary : $ 100,000 - 135,000 per year
Job Description:
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 looking for an experienced Senior Engineer to join their team. The position requires excellent communication skills in Japanese and English, a strong technical background, and a passion or interest for the medical device industry. You will play a vital role in supporting the company’s sales as well as product development and implement efforts by contributing the technical expertise during the phase of understanding the customer requirements, developing proposals, coordinating with oversea teams for project progression from prototype to mass production.
Essential Duties and Responsibilities Include but not are Limited to: • Work closely with sales teams and their customers to understand needs and identify technical requirements for products to meet their needs. • Prepare and maintain engineering documentation, including design specifications, test protocols, and technical reports. • Contribute to the sales team in the development of account strategies and proposals by providing insights as a technical expert. • Respond to technical inquiries from prospective and current customers regarding products and services, providing clear and concise information. • Accompany sales representatives on client visits to understand customer needs when needed, to present technical solutions and contribute to effective proposals. • Develop and deliver compelling product presentations and demonstrations, showcasing the technical capabilities and benefits of the company’s offerings. • Prepare accurate and comprehensive technical responses for Requests for Proposals (RFPs). • Stay current with industry trends, attending tradeshows, conferences, and other relevant events. • Provide technical guidance and mentorship to junior engineering staff and sales teams. • Coordinate with overseas teams throughout the product lifecycle, from prototype to mass production, ensuring seamless project progression. • Manage change requests initiated by the quality team, ensuring accurate communication to customers, understanding internal processes, and collaborating with the quality team for implementation. • Play a crucial role in managing customer quality-related issues, ensuring effective communication between the company and its clients, and driving resolution. • Apply corrective and preventive actions (CAPA) based on customer feedback, driving continuous improvement. • Review quality reports and deliver clear and concise reports to customers. • Collaborate with overseas teams throughout the entire product lifecycle, from prototype to mass production, ensuring seamless project progression. This includes coordinating with overseas teams to ensure customer requirements are met during the validation process, reviewing and approving validation documents (protocols, reports, deviations), and may occasionally require working late evenings due to different time zones. • Perform other duties as assigned by management.
Qualifications: • Bachelor’s or Master’s degree in Mechanical Engineering, Biochemical Engineering, or a related field. • 5+ years of engineering experience, including experience in preparing and maintaining engineering documentation. • Bilingual Japanese and English (writing, speaking, and reading). • Ability to travel domestically and internationally.
Preferred Qualifications: • Experience in the medical device industry, with a strong understanding of relevant regulations and standards (e.g., FDA, ISO 13485). • Experience with medical device finished products, and or metallic and polymer materials.
Pay range minimum: $ 100,000.00
Pay range maximum: $ 135,000.00
The base pay range above represents the low and high end of the base compensation range we reasonably expect to pay for this position. Actual base compensation will vary and may be above or below the range based on a range of factors including, but not limited to, geographic location, actual experience, and job performance. This job posting is not a promise of any specific pay for any specific employee.
The range listed is just one component of the total compensation package for our employees. Based on the details of your position, we provide a variety of benefits to our employees, including medical, dental, and vision plans, pre-tax savings plans, pre-tax parking and commuter plans, supplemental health and welfare plans, a retirement savings plan, an employee assistance program, pet insurance, and paid holidays. Other rewards may include short-term incentives and paid time off.
Overview: A leading provider of high-quality medical device components is looking for an experienced Senior Engineer to join their team. The position requires excellent communication skills in Japanese and English, a strong technical background, and a passion or interest for the medical device industry. You will play a vital role in supporting the company’s sales as well as product development and implement efforts by contributing the technical expertise during the phase of understanding the customer requirements, developing proposals, coordinating with oversea teams for project progression from prototype to mass production.
Essential Duties and Responsibilities Include but not are Limited to: • Work closely with sales teams and their customers to understand needs and identify technical requirements for products to meet their needs. • Prepare and maintain engineering documentation, including design specifications, test protocols, and technical reports. • Contribute to the sales team in the development of account strategies and proposals by providing insights as a technical expert. • Respond to technical inquiries from prospective and current customers regarding products and services, providing clear and concise information. • Accompany sales representatives on client visits to understand customer needs when needed, to present technical solutions and contribute to effective proposals. • Develop and deliver compelling product presentations and demonstrations, showcasing the technical capabilities and benefits of the company’s offerings. • Prepare accurate and comprehensive technical responses for Requests for Proposals (RFPs). • Stay current with industry trends, attending tradeshows, conferences, and other relevant events. • Provide technical guidance and mentorship to junior engineering staff and sales teams. • Coordinate with overseas teams throughout the product lifecycle, from prototype to mass production, ensuring seamless project progression. • Manage change requests initiated by the quality team, ensuring accurate communication to customers, understanding internal processes, and collaborating with the quality team for implementation. • Play a crucial role in managing customer quality-related issues, ensuring effective communication between the company and its clients, and driving resolution. • Apply corrective and preventive actions (CAPA) based on customer feedback, driving continuous improvement. • Review quality reports and deliver clear and concise reports to customers. • Collaborate with overseas teams throughout the entire product lifecycle, from prototype to mass production, ensuring seamless project progression. This includes coordinating with overseas teams to ensure customer requirements are met during the validation process, reviewing and approving validation documents (protocols, reports, deviations), and may occasionally require working late evenings due to different time zones. • Perform other duties as assigned by management.
Qualifications: • Bachelor’s or Master’s degree in Mechanical Engineering, Biochemical Engineering, or a related field. • 5+ years of engineering experience, including experience in preparing and maintaining engineering documentation. • Bilingual Japanese and English (writing, speaking, and reading). • Ability to travel domestically and internationally.
Preferred Qualifications: • Experience in the medical device industry, with a strong understanding of relevant regulations and standards (e.g., FDA, ISO 13485). • Experience with medical device finished products, and or metallic and polymer materials.
Job Number: 1877374
Zip Code: 92780
Pay range minimum: $ 100,000.00
Pay range maximum: $ 135,000.00
The base pay range above represents the low and high end of the base compensation range we reasonably expect to pay for this position. Actual base compensation will vary and may be above or below the range based on a range of factors including, but not limited to, geographic location, actual experience, and job performance. This job posting is not a promise of any specific pay for any specific employee.
The range listed is just one component of the total compensation package for our employees. Based on the details of your position, we provide a variety of benefits to our employees, including medical, dental, and vision plans, pre-tax savings plans, pre-tax parking and commuter plans, supplemental health and welfare plans, a retirement savings plan, an employee assistance program, pet insurance, and paid holidays. Other rewards may include short-term incentives and paid time off.
