- Design machines and equipment for medical device production, both within and outside clean room environments.
- Initiate new equipment and tooling design projects by collating requirements and product specifications.
- Conduct economic analyses and calculate return on investment to substantiate new equipment investments.
- Create machine shop and assembly drawings; oversee component acquisition and coordinate electromechanical equipment assembly.
- Develop test methods and validation reports to support and qualify existing or new equipment and processes.
- Analyze and resolve production issues efficiently.
- Strategically aim for and implement cost-saving measures.
- Perform additional duties as assigned.
- Other duties as assigned.
- Bachelor's degree in mechanical engineering or other related fields.
- 7 years of demonstratable experience in a similar role.
- Proficient in hands-on mechanical design using SolidWorks for precise engineering.
- Specialized in medical device manufacturing equipment and processes, ensuring expertise in industry-specific standards.
- Demonstrates a robust understanding of mechanical engineering theories and principles.
- Familiarity with industrial machine control concepts, encompassing motors, sensors, and other related electrical components.
- Conducts production method analyses and offers proposals for enhancing or introducing new manufacturing processes.
- Skilled in adhering to FDA ISO 13485 and 21 CFR, part 820 requirements for regulatory compliance.
- Effective in presenting engineering investigations and findings to management, showcasing strong communication and presentation abilities.
- Proficient with engineering statistical analysis, DOE, Process Capability, and similar methodologies using Minitab software, ensuring data-driven decisions.
- Demonstrates strong interpersonal and communication skills vital for collaborative engineering environments.
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Manufacturing Engineer III - Irvine, United States - Inari Medical
Description
The Manufacturing Engineer III (Advanced Projects), designs and improves manufacturing processes by implementing automated equipment and tooling, adhering to precise product specifications and quality standards within a collaborative engineering team. Furthermore, conducts thorough analyses of both the design and manufacturing processes, focusing on enhancing producibility, quality, and cost-effectiveness for both existing and new products.
Responsibilities
Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.