The individual will contribute to the development of existing and new medical technologies and applications.
Duties and Responsibilities:
- Define and guide the development of elegant mechanical designs that meet requirements for product performance, cost, reliability, and manufacturability.
- Develop designs for all phases of product development, from proof-of-concept through manufacturing.
- Drive design verification by testing design performance in the lab and design validation by developing fast-turn clinical prototypes for use in research clinics.
- Contribute regularly to technical design reviews, project scheduling, and the development of new product concepts and applications.
- Use FEA simulation tools to model mechanical assemblies and guide design development.
- Perform other duties as assigned.
Position Requirements:
- B.S. in Mechanical Engineering with 5+ years of related mechanical design experience for capital equipment, lasers, or medical devices. Graduate degree is a plus.
- Experience in designing opto-mechanical assemblies. Experience with designing mechanical actuation assemblies such as laser beam scanning systems, translation and rotation stages is a plus. Knowledge of strain-free mounting techniques for optics using adhesives is also a plus.
- Strong understanding of GD&T principles and ability to evaluate and apply them to precision mechanical designs.
- Proven CAD design experience of 10+ years, with SolidWorks preferred.
- Extensive knowledge of manufacturing technologies including plastic injection molding, sheet metal manufacturing, and high-precision machining.
- Proven communication skills and the ability to make design recommendations based on cross-functional inputs (Engineering, Clinical, Manufacturing, Quality, and Regulatory).
- Ability to apply FEA simulation tools to develop designs by correlating simulation results with empirical test data.
- Basic knowledge of electronics, optics, and numerical data analysis (Excel, Matlab, or equivalent). Data acquisition skills such as LabView are a plus.
- Familiarity with FDA Quality Systems Regulations/Design Control requirements and their application from design inception to manufacturing release.
- Knowledge and experience with IEC 60601 compliance standards and ISO 14971 Risk Management requirements and techniques.