Responsible for providing mechanical engineering support in the creation and the development of new medical device products (invasive and non-invasive).
Job Responsibilities:
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:
Education : Bachelor’s degree in Mechanical Engineering or a related field.
Experience : 5 years of working experience in R&D or a related field, or an equivalent combination of education and experience.
Technical Knowledge : Familiarity with ISO13485 and Design Control.
Communication Skills : Well-balanced communication skills to interact with all stakeholders.
Language Skills :
Japanese: Fluent in speaking, writing, and reading (preferred).
English: Fluent in speaking, writing, and reading.
Skills : Attention to detail and ability to multitask.
Travel : Ability to travel to supplier and/or other manufacturing sites, and customer sites, if necessary.