
Manufacturing Engineer
- Irvine, CA
- $45.00-55.00 per hour
- Permanent
- Full-time
- Develop and implement robust manufacturing processes for existing products.
- Ensure a seamless transition from product development to full-rate production, ensuring process stabilization.
- Develop and qualify new tooling and equipment to enhance production capabilities.
- Design and draft workspace layouts, including materials and equipment, using computer-aided design (CAD) software.
- Update risk documents (FMEA’s) and Quality Control Plans for New Product Introduction.
- Conduct verification and validation (IQ/OQ/PQ) of processes, machines, and equipment to meet company procedures and regulatory requirements.
- Create and maintain routers and standards for manufacturing processes.
- Troubleshoot product and process-related issues, performing root cause analysis and implementing corrective and preventative action plans.
- Collaborate with vendors to identify and implement operational equipment and automation solutions.
- Develop and manage project plans for major operational improvement activities.
- Minimum of 2 years of experience working as a Manufacturing Engineer in the medical device industry.
- Experience in process development and process improvement.
- Supporting Design Transfer and process improvement for class III medical devices, including catheters.
- Bachelor’s Degree in Engineering or a related field.
- Proven experience in manufacturing process validation.
- Excellent communication and technical writing skills for preparing reports and collaborating with cross-functional teams.
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)