Senior Engineer – (JE) ‐ Engineer

A Medical Device company in Orange County, CA is looking for a Senior Engineer – (JE)

Job Description

• Address technical inquiries regarding our products and services.
• Travel to customer sites alongside Sales Representatives when required.
• Coordinate internal technical resources to prepare and deliver compelling product presentations/demonstrations.
• Actively contribute to account strategy definition and review.
• Perform needs-assessment analysis; provide problem-solving solutions.
• Utilize technical expertise to understand the customer’s needs and provide technical solutions.
• Define product and technical responses for RFP requests in a timely manner.
• Participate in tradeshows, conferences, and other events as needed.
• Demonstrate a thorough understanding of products, features, and functions.
• Provide education and training to peers, sales staff, and others within the organization.
• Maintain close communication with overseas teams and prepare necessary documents for the development-to-production transition.
• Understand and adhere to internal procedures.
• Manage and organize all documentation, ensuring proper control and adherence to company standards and procedures.
• Handle change requests initiated by the Asahi quality team, ensuring accurate information is communicated to the customer, understanding the required actions based on the customer’s processes, and working closely with the quality team to implement the change.
• Manage customer complaints by obtaining necessary information, assisting in creating customer complaint reports, and initiating the review of Corrective and Preventive Actions.
• Review quality reports issued by the quality team and deliver well-written reports to customers.
• Collaborate with the team in Japan throughout the validation process by thoroughly understanding customer requirements, providing valuable insights, reviewing validation protocols and reports, and effectively addressing any customer inquiries or feedback.
• Ability to work flexible hours, including late evenings, as occasional meetings across different time zones may be required.
• Any other tasks as requested by management.

Requirements

• Bachelor’s or Master’s degree in Mechanical Engineering, Biochemical Engineering, or a related field.
• Must have at least 5 years of engineering experience, preferably within the medical industry or related fields.
• Proficient in both Japanese and English, with strong verbal and written communication skills in both languages.
• Ability to work collaboratively in a team-oriented environment.
• Self-motivated and proactive, with the ability to work independently and take initiative in achieving goals and meeting deadlines.
• Excellent problem-solving skills and attention to detail.
• Demonstrated ability to work effectively with diverse cultures and a strong understanding of varying work ethics across different countries.
• Exhibits flexibility in thinking, adaptability to changing circumstances, efficiency in work, and a strong willingness to continuously learn and grow.
• Experience in preparing and maintaining engineering documentation, such as design specifications and test protocols.
• Ability to travel domestically and internationally.
• Strong knowledge of medical device regulations and standards
• Previous materials experience (metallic/polymer)
• Previous experience in medical devices, finished products.
• Experience in project management, including leading and coordinating cross-functional teams in the development of medical devices.
• Familiarity with quality management systems and quality assurance processes in the medical device industry.