Principal Mechanical Engineer for Medical Innovations
2 weeks ago
The successful candidate will play a pivotal role in advancing both current and innovative medical technologies and applications.
Key Responsibilities:
- Craft and oversee the development of sophisticated mechanical designs that fulfill criteria for product efficacy, cost-effectiveness, durability, and manufacturability.
- Create designs throughout all stages of product development, from initial proof-of-concept to full-scale manufacturing.
- Lead design verification through laboratory testing of design performance and validation by creating rapid clinical prototypes for research applications.
- Actively participate in technical design evaluations, project timelines, and the ideation of new product concepts and applications.
- Employ FEA simulation tools to model mechanical assemblies and inform design evolution.
- 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 systems, or medical devices. A graduate degree is advantageous.
- Proficient in designing opto-mechanical assemblies. Experience with mechanical actuation systems, such as laser beam scanning mechanisms and translation/rotation stages, is beneficial. Familiarity with strain-free mounting techniques for optics using adhesives is a plus.
- Strong grasp of GD&T principles with the ability to assess and apply them to precision mechanical designs.
- Demonstrated experience of 10+ years in CAD design, with SolidWorks being preferred.
- In-depth 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 interdisciplinary feedback (Engineering, Clinical, Manufacturing, Quality, and Regulatory).
- Competence in utilizing FEA simulation tools to develop designs by correlating simulation outcomes with empirical test results.
- Basic understanding of electronics, optics, and numerical data analysis (Excel, Matlab, or equivalent). Skills in data acquisition, such as LabView, are a plus.
- Familiarity with FDA Quality Systems Regulations/Design Control requirements and their application throughout projects from design initiation to manufacturing release.
- Knowledge and experience with IEC 60601 compliance standards and ISO 14971 Risk Management requirements and methodologies.
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