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Manufacturing Engineer

Prismatik -
Irvine, CA

Job Details

Full-time
$34 - $37 an hour

Qualifications

Composite materials
Bachelor's degree in mechanical engineering
New product introduction
Operational analysis
Space planning
Production data analysis
Machine operation
Bachelor of Science
Document control experience within engineering industry
Mechanical Engineering
Document control experience within manufacturing industry
Technical writing experience within manufacturing
Data analysis skills
Engineering process optimization
Injection (injection molding)
Mid-level
Factory operations documentation
Master's degree
Manufacturing standard operating procedures
Manufacturing facility experience
Mechanical drawings
Collaboration with product development teams
Bachelor's degree in engineering
Medical device manufacturing facility experience
Materials Engineering
Quality issues
Collaboration with manufacturing teams
Design controls
Manufacturing Engineering
Biomedical regulatory compliance

Full Job Description

We're looking for a Manufacturing Engineer to help scale and optimize the processes behind our advanced dental materials.

This is a hands-on role where you'll work directly with a wide range of manufacturing equipment and machinery, learning how our processes operate and identifying opportunities to improve them. You'll partner with manufacturing, R&D, quality, and engineering teams to troubleshoot production challenges, implement process improvements, and support new product introductions that improve safety, quality, and efficiency.

Essential Functions:

Works alongside Materials Manufacturing team to learn and understand the equipment and processes in Material Manufacturing areas: BruxZir Colloidal, BruxZir Pressed, BruxZir Now, Composites, Resin, Obsidian, and Injection Molding.
Provides engineering support by thoroughly understanding the functions of the various processes, products, and need of customers.
Assists with troubleshoot and resolution of any issues or defects that may occur in the manufacturing process through application of hands-on skills and assessment of manufacturing machine program.
Assesses process improvements under FDA design control and ISO 13485 change control guidelines.
Understands lean manufacturing concepts and manufacturing flow to assist with definition, maintenance, and continuous improvement of process steps required to create customer products and processes.
Assists with implementation of new and existing manufacturing process to improve safety, quality, and costs.
Collaborates with team to analyze process data to evaluate effectiveness of manufacturing processes provides recommendation for improvements based on analysis.
Assists with creation of work instructions, standard operating procedures (SOPs), and process related documents including but not limited to forms and certifications.
Assists with generation of work packages including but not limited to detailed manufacturing instructions, drawings, bills of material (BOMs), references, and inspection requirements required to control production work.
Assists with production request to avoid any delays in manufacturing.
Analyzes and plans workflow, space requirements, and equipment layout to improve manufacturing efficiency.
Collaborates with various departments to execute projects and tasks, including but not limited to Manufacturing, Engineering, R&D, Document Control, and RA/QA.

Minimum Qualifications:

Bachelor of Science in Manufacturing, Mechanical, or Materials Engineering, or any equivalent education and/or experience from which comparable knowledge, skills and abilities have been demonstrated/achieved. Master’s degree a plus.
Previous experience in medical device manufacturing, a plus.

Pay Range: $34.00-$37.00/hr

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