R&D Engineer II

ASAHI INTECC USA INC•Tustin, CA

2d•Remote

About The Position

This role is responsible for the design and development of medical devices and related accessories. The engineer will develop and execute engineering tests, create comprehensive protocols and reports, and develop tools, jigs, and fixtures. They will also create preliminary sketches, detailed design concepts, perform measurements, analyses, and create engineering prototypes. Communication of project status, risks, and opportunities to the project team and management is essential, as is contributing to the company's intellectual property. The role involves assembling product drawings, specifications, risk analysis, and technical documents, ensuring proper documentation within the Design Dossier and Design History File (DHF) for regulatory compliance. Responsibilities also include contributing to product transfer and scale-up activities, ensuring compliance with quality system procedures and regulations, maintaining the R&D laboratory, and potentially managing direct or indirect reports. General office duties are also part of the role.

Requirements

Good analytical, critical thinking, and problem-solving skills.
Great team player.
Have a sense of urgency, ability to multitask, ability to prioritize activities, manage risks, and complete tasks on time.
Excellent oral and written communication along with good presentation and technical writing skills.
Have working proficiency using SolidWorks for 3D modeling and drafting engineering drawings.
Bachelors or higher degree in Biomedical, Materials, or Mechanical Engineering
Minimum 2-years working experience as engineer in development or manufacturing role, in a regulated medical device environment.

Nice To Haves

Functional familiarity with the FDA Submission process, ISO Requirements and QSR requirements is also preferred.
Preference given to candidates with experience in endovascular catheter industry.

Responsibilities

Design and develop medical devices and related accessories.
Develop and execute engineering tests, including benchtop, verification & validation (V&V), and pre-clinical studies.
Create comprehensive protocols and reports.
Develop tools, jigs, and fixtures to support prototyping, manufacturing, and testing.
Create preliminary sketches and detailed design concepts, perform measurements, analyses, and create engineering prototypes.
Communicate project status, risks, and opportunities to project team and management.
Contribute to the intellectual property base of the Company via active idea generation and communication of new concepts to management.
Assemble product drawings, specification, risk analysis and necessary technical documents.
Ensure proper documentation of product designs within Design Dossier and Design History File (DHF) for regulatory compliance and filing purposes.
Contribute to product transfer and scale-up activities.
Ensure compliance with quality system procedures, all applicable federal, state, and local regulations, as well as company policies related to Health, Safety, and Environmental practices.
Maintain R&D laboratory to facilitate efficient prototype and process development.
Manage direct or in-direct report(s) as required.
Other general office duties as required.