R&D Engineer II
On-siteTustin, California, United States
Job Summary
Design and develop medical devices and related accessories, including creating preliminary sketches, detailed design concepts, and engineering prototypes. Execute engineering tests such as benchtop, verification and validation, and pre-clinical studies while developing tools, jigs, and fixtures to support prototyping and manufacturing. Assemble product drawings, specifications, and risk analysis to ensure proper documentation within the Design Dossier and Design History File for regulatory compliance. Maintain the R&D laboratory to facilitate efficient prototype and process development, and contribute to product transfer and scale-up activities. Communicate project status, risks, and opportunities to the team and management.
Required Qualifications
- Good analytical, critical thinking, and problem-solving skills
- Great team player
- Sense of urgency
- Ability to multitask
- Ability to prioritize activities
- Ability to manage risks
- Ability to complete tasks on time
- Excellent oral and written communication
- Good presentation skills
- Good technical writing skills
- Ability to travel approximately 5% of the time throughout the United States and internationally
- Ability to travel to Temecula as needed for development and product transfer
- 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
Desired Qualifications
- Functional familiarity with the FDA Submission process, ISO Requirements and QSR requirements
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.