Lead Mechanical Engineer for Medical Innovations

1 week ago


Los Angeles, California, United States Analog Group Inc Full time
Position Overview:
The selected candidate will play a crucial role in advancing both established and emerging medical technologies and applications.

Key Responsibilities:
- Define and oversee the creation of sophisticated mechanical designs that fulfill criteria for product performance, cost-effectiveness, reliability, and manufacturability.
- Develop designs across all stages of product development, from initial proof-of-concept to full-scale manufacturing.
- Propel design verification by assessing design performance in laboratory settings and facilitate design validation through the creation of rapid clinical prototypes for research purposes.
- Actively participate in technical design evaluations, project timelines, and the ideation of new product concepts and applications.
- Utilize FEA simulation tools to model mechanical assemblies and inform design processes.
- Undertake additional responsibilities as required.

Qualifications:
- Bachelor’s degree in Mechanical Engineering with over 5 years of relevant mechanical design experience in capital equipment, laser technology, or medical devices; a graduate degree is advantageous.
- Proficient in designing opto-mechanical assemblies, with experience in mechanical actuation systems such as laser beam scanning and translation/rotation stages considered a plus.
- Strong grasp of GD&T principles, with the ability to assess and implement them in precision mechanical designs.
- A minimum of 10 years of CAD design experience is essential, with SolidWorks being the preferred software.
- Comprehensive knowledge of advanced manufacturing technologies, including plastic injection molding, sheet metal fabrication, and high-precision machining.
- Excellent communication skills with the capability to make design recommendations based on collaborative inputs from various departments (Engineering, Clinical, Manufacturing, Quality, and Regulatory).
- Ability to leverage FEA simulation tools to refine designs by correlating simulation outcomes with empirical testing data.
- Basic understanding of electronics, optics, and numerical data analysis tools (Excel, Matlab, or equivalent); familiarity with data acquisition tools like LabView is a plus.
- Awareness of FDA Quality Systems Regulations/Design Control requirements and their application throughout the project lifecycle from design initiation to manufacturing release.
- Knowledge and experience with IEC 60601 compliance standards and ISO 14971 Risk Management practices.

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