Be a part of a well funded start up that is making an impact in peoples lives!
This Jobot Job is hosted by: Ryan Jauregui
Are you a fit? Easy Apply now by clicking the "Apply on company site" button and sending us your resume.
Salary: $65,000 - $90,000 per year
A bit about us:
We are a biotechnology company based in Los Angeles, CA focused on providing prompt diagnostic testing results for diseases, infections, and contaminations.
Why join us?
- Competitive Salary!
- 401(k) with Company Match!
- Dental, Health, and Vision Insurance!
- Paid Time Off!
We are looking to add a Manufacturing Engineer to our Engineering team.
- Supports all aspects of design, development, and manufacturing for small form factor consumable medical device test materials.
- Supports lower volume prototype and clinical validation manufacturing and bridges manufacturing as it scales.
- Partners with internal team members and vendors to optimize product performance.
- Performs troubleshooting and routine maintenance of complex manual and automated manufacturing processes.
- Helps identify and vet manufacturing processes and qualify manufacturing suppliers.
- Works with vendors to optimize product performance, asses, and recommend new technologies.
- Collects analyzes, and reporting of data to determine the performance and reliability of the product.
- Makes design and technical decisions and contributes to solving complex manufacturing engineering problems.
- Assists with NCR investigations, write-ups, and product dispositions.
- Identifies previously unknown process variables and implementing best practices.
- Performs FMEA to identify root causes of problems and present possible solutions.
- Generates technical documentation including specs, control drawings, work instructions, technical reviews, studies, and executive summaries.
- Troubleshoots and maintenance of manufacturing equipment.
- Performs duties in a cleanroom environment.
- Develops and executes validation of new equipment and processes consistent with FDA standards.
- 5-8 years experience in a manufacturing environment within the Biotechnology and/or pharmaceutical industry.
- Bachelor's Degree in Mechanical or Manufacturing Engineering degree required (M.S. preferred but not required).
- Experience in manufacturing, equipment changes, process change, and product line extension change.
- Hands-on experience in dFMEA, pFMEA, risk analysis, and management.
- Previous experience with product impact assessments and CAPAs.
- Working knowledge of Lean, Six Sigma, or Design for Reliability and Manufacturing.
- Highly proficient with Solid Works and other modeling software.
- Experience with scaling to high-volume device manufacturing/automation (medical, biotech, consumer electronics).
- Prior experience working in a start-up environment is highly preferred.
- Maintain the ability to work in a high production environment.
- Demonstrated decision-making skills.
- Excellent leadership skills.
Interested in hearing more? Easy Apply now by clicking the "Apply on company site" button.