Company Background: Manufacturing

Industry: Medical Devices

Position: R&D Engineer

Tenure: Permanent

Headcount: 1

Job descriptions:

• Support and successfully contributes to project teams through the following activities: product design and development, test of materials, preparation of specifications, process capability studies, research investigations (animal/Ex vivo studies), report preparation, and process/test documentation.
• Translates customer needs into product requirements and design specifications.
• Supports solutions to a variety of problems of simple scope and complexity where analysis of situations or data requires a review of identifiable factors.
• Summarizes, analyzes, and draws conclusions from test results.
• Prepares standard reports/documentation to communicate results to technical community.
• Assist in troubleshooting on new products/process problems as related to design, material, or process.
• Engages with internal company and external contacts. Represents organization on specific projects. Uses diplomacy and tact in interactions and problem solving.
• Train, technicians/operators on new processes and/or test procedures Support concepts and designs for new products/processes, and submits idea disclosures.
• Applies the Technical Development Process (TDP)/Product Development Process (PDP) methodologies.
• Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing on projects of varying complexity to ensure project success. Responsible for engineering documentation.
• Designs and coordinates standard engineering tests and experiments.
• Designs, procures, and fabricates tooling and fixtures.

Job Requirements:   

• Bachelor’s degree in Mechanical Engineering or a related field.
• 2-5 years of working experience in R&D or a related field, or an equivalent combination of education and experience.
• Familiarity with ISO13485 and Design Control.
• Well-balanced communication skills to interact with all stakeholders
• Japanese & English: Fluent in speaking, writing, and reading