100% onsite - Ventura, CA

6 month extendable CONTRACT

$45 - $55 per hr

MUST HAVE:

• Engineering degree and 5 years of relevant work experience
• Process or Manufacturing Engineering experience
• Mechanical assembly background.
• Experience in medical devices, pharma or biotech - ideally medical devices

Nice to have:

• Electrical engineering or silicone processing experience
• Medical device experience including IQ/OQ/PQ
• Tooling design
• Six sigma or similar structured problem solving (DMAIC, 8D, PDCA, etc)
• Packaging and/or labeling for FDA approved products

Key Responsibilities :

• Technical and engineering resource to the production of product and components from receipt through final inspection.
• Process development and validation
• Tooling and equipment
• Engineering and production documentation
• Ensure product is manufactured in accordance with engineering best practices, AVITA’s quality system, international standards and regulations, and specific AVITA requirements.
• Troubleshooting and problem solving, including root cause analysis.
• Implement corrective and preventive actions for production non-conformances.
• Continuous process monitoring, evaluation, and improvement for quality, efficiency, and costs.
• Use AVITA’s Document Control system to keep production documentation current and accurate.
• Support concurrent engineering efforts by participating in design development projects.
• Design, document, and implement methods for process control, process improvement, testing, and inspection.
• Lead Design and Tech transfer projects for product and process changes, including qualifying alternate suppliers.
• Participate in change control, material review boards, quality system reviews as the engineering representative.
• Evaluate current and prospective suppliers and establish requirements.
• Other duties as assigned