PURPOSE OF POSITION:
The Mechanical Engineer will perform mechanical design and analysis for electro mechanical components for the ASANTE (http://asantesolutions.com/) product. In this role you work closely with other engineering teams and suppliers in design / development & production of components, support manufacturing & assembly, complete technical root cause analysis of field failures.
ESSENTIAL DUTIES AND RESPONSIBILITIES may include but not limited to:
- Design and development of mechanical and electromechanical systems from marketing specifications; using principles of DFM and DFA.
- Evaluate mechanical and electromechanical systems and assemblies by application of principles of mechanics and materials.
- Confirm system and product capabilities by designing feasibility and testing methods and systems.
- Develop manufacturing processes by designing and modifying equipment for fabricating, building, assembling, and installing components.
- Assure system and product quality by following design control process
- Maintain quality assurance by SPC/SQA methods.
- Contribute to team effort by performing various duties as requirements arise.
- Transfer product to mfg
- Work with offshore contract manufactures to resolve issues
EXPERIENCE REQUIREMENTS:
§ Minimum 8 years of Mechanical Engineering experience
§ Medical device industry experience required.
§ Start up company experience required.
§ 3-D modeling, design, failure analysis, conceptualization, and presentation skills with a quality focus, a plus
§ SolidWork experience is required
§ Production planning, product management and experience with prototype fabrication a plus.
§ MS Office Suite experience.
§ Experience in preparation and documentation required for ISO, FDA audits
§ Familiar with design control processes
Thanks,
Wenkang
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