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 contribute 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.
Translate customer needs into product requirements and design specifications.
Support solutions to a variety of problems of simple scope and complexity where analysis of situations or data requires a review of identifiable factors.
Summarize, analyze, and draw conclusions from test results.
Prepare standard reports/documentation to communicate results to the technical community.
Assist in troubleshooting on new products/process problems as related to design, material, or process.
Engage with internal company and external contacts.
Represent the organization on specific projects.
Use 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 submit idea disclosures.
Apply the Technical Development Process (TDP)/Product Development Process (PDP) methodologies.
Work cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing on projects of varying complexity to ensure project success.
Responsible for engineering documentation.
Design and coordinate standard engineering tests and experiments.
Design, procure, and fabricate tooling and fixtures.
Job Requirements:
Education : Bachelor's degree in Mechanical Engineering or a related field.
Experience : 2-5 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.#J-18808-Ljbffr