Senior Manufacturing Sustaining Engineer - San Jose
San Jose, CA
Sponsor H1-B visa - Must be currently residing in the US.
Must be currently residing in the US.
Supports the manufacturing of Rani Capsules. Works with engineering and quality to ensure device specifications conform to device requirements. Responsible for supporting the production lines with daily activities, process improvements, cost savings projects, customer/vendor changes, and consistency of assembly processes.
- Evaluate the current manufacturing processes /workflows to identify opportunities for improving
- Improve manufacturing efficiency, production yields, product quality, and consistency through equipment and product design, modifications, and fabrication.
- Modify and improve existing equipment.
- Complete projects, report status, and document lessons learned in an efficient manner.
- Finalize manufacturing methods for medical devices.
- Provide assistance for equipment design or producing medical devices and components.
- Support production and manufacturing.
- Engineering support which includes vendor contact and auditing specification.
- Responsible for implementing tooling maintenance and upgrades.
- Responsible for manufacturing methods and their transfer into production.
- Follow SOP on re-validation of existing equipment, tooling and processes.
- Develop improved processes, sampling activities, as well as tooling and manufacturing concepts that will meet customer expectations on cost, quality and delivery.
- Provide technical assistance and engineering support to the manufacturing floor in ensuring production of quality products. Work with other support departments to maintain on-time delivery of goals.
- Lead process improvement and waste elimination efforts through application of lean principles and actively participate in continuous improvement events.
- Work with Quality Control team to generate, update and implement all project related requests, process guides, and troubleshooting guides.
- Performs Root Cause Analysis and Addresses CAPA on Manufacturing Non Conformances
- Create comprehensive Manufacturing Documentation (MPI's, LHR's, WI's)
- BS in Mechanical Engineering, Manufacturing Engineering, or similar related field
- 7+ years of engineering experience in manufacturing preferred
- MiniTab (or other statistical analysis software), SolidWorks or CAD modeling software.
- Experience in new product development, introduction processes and procurement protocols
- Must be detail oriented, focused and able to produce accurate and professional documents
- Must have excellent interpersonal skills and ability to communicate needs and demands in an effective manner.
- Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
- Required Knowledge, Skills, and Abilities: (Submission Summary):
1. BS in Mechanical Engineering, Manufacturing Engineering, or similar related field
2. 7+ years of engineering experience in manufacturing
3. MiniTab (or other statistical analysis software), SolidWorks or CAD modeling software.
4. Experience in new product development, introduction processes and procurement protocols
5. Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc.
6. MS in Mechanical Engineering, Manufacturing Engineering, or similar related field - NICE TO HAVE:
7. Experience in new product development, introduction processes and procurement protocols - NICE TO HAVE:
8. Salary Expectation?
9. Complete Current Address?
10. Write a cover letter explaining how you are a good fit for this position
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