Manufacturing Process Engineer
4 days ago
O2 Concepts, LLC is seeking an experienced Manufacturing Process Engineer to join our team. The successful candidate will be responsible for sustaining and improving the processes required to manufacture a medical device under the guidance of an ISO 13485 Quality Management System, FDA requirements, and other international standards.
Responsibilities:- Sustain and improve processes required to manufacture a medical device.
- Lead technical resource for Quality, RMA and Technical Support.
- Develop design recommendations to improve product reliability and performance.
- Develop, test, and implement design changes as well as coordinate with suppliers and manufacturers to ensure smooth implementation.
- Provide technical resource regarding equivalency in value engineering and analysis for current components and future product development projects.
- Manage Bill of Materials across multiple product lines.
Requirements:
- 5+ years of experience in a manufacturing environment required.
- Bachelor's degree in Engineering (Mechanical, Manufacturing or Biomedical) required.
- Working knowledge of AS 9100, ISO 9001 and/or ISO 13485 preferred
- Proficient In CAD with SolidWorks expertise preferred.
- Knowledge of manufacturing operations, process verification and validation, geometric dimensioning and tolerancing (GD&T) including the ability to create and understand prints and specifications.
- Ability to organize and prioritize workflow across multiple projects to meet established time frames and schedules.
This is an exempt; full-time position with a salary range of $125,000 - $160,000 per year, depending on experience and education. Benefits include a matching 401K, health, dental, vision and paid time off.
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