Manufacturing Engineer (2nd Shift)
$79,000–$119,000 year
On-site · Calabasas, California, United States
Job Summary
Manufacturing Engineer (2nd Shift) supporting Liquid Silicone Rubber (LSR) molding operations. Responsible for driving process optimization, validating robust manufacturing processes, and leading revalidation activities for changes. Works to improve productivity, cycle time, and material utilization while ensuring ISO 13485 and FDA compliance. Collaborates with cross-functional teams and vendors to deliver high-quality medical devices, leads root-cause investigations, coordinates equipment procurement and commissioning, develops and maintains validation protocols (IQ/OQ/PQ), PFMEAs, and control plans, and pursues automation initiatives including robotics and lights-out manufacturing.
Required Qualifications
- Bachelor’s degree in mechanical engineering, Plastics Engineering, Manufacturing Engineering, or a related field
- Minimum 3+ years of experience in Manufacturing Engineering (Ideally with Injection Molding/LSR Manufacturing)
- Experience supporting production lines in 24X7 environments
- Hands-on experience with Molding machines and robotic automation
- Proven track record in leading and supporting engineering projects in highly collaborative environments
- Strong knowledge of quality systems (ISO 13485, FDA regulations) and validation protocols
- Proficient in CAD software (e.g., SolidWorks) and data analysis tools (e.g., Minitab, JMP)
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