Job Title: R&D Engineer

Location: Irvine, CA, 92614

Duration: 6 Months Contract (Good Possibilities of extension)

How you will make an impact:

• Support areas of Quality Assurance, Design Controls, Risk Management, Manufacturing Controls, and Statistical Techniques for New Product Development (NPD) programs
• Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
• Coordinate and execute change control activities to support rapid innovation
• Support design and development activities (i.e., engineering study, feasibility testing, drawing review, etc.)
• Participate in escalation tasks and activities, including Project Risk Assessments (PRA)
• Supports or leads test method development/validation activities for Design Verification testing and manufacturing inspections for NPD programs
• Collaborate with R&D and Manufacturing organizations to facilitate the successful execution of the NPD process and launching of robust products
• Develop complex experiments and tests (including writing and executing protocols) to create, improve, and validate products and manufacturing processes by analyzing results, making recommendations, and developing reports
• Develop, update, and maintain technical content of risk management files
• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
• Assign and oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
• Other incidental duties assigned by Leadership
• Ability to travel up to 10% domestically and internationally

What you'll need (Required Qualifications):

• Bachelor's degree in engineering or Scientific field with a minimum of (2) years of experience in either NPD, Quality Engineering, R&D, and/or Manufacturing; OR a master's degree in engineering or Scientific field with internship, senior projects, or thesis experience required.
• Engineering experience within a highly regulated industry

What else we look for (Preferred Qualifications):

• Experience in medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
• Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process Validation
• Experience with root cause analysis or investigations for Complaints, NCRs, and/or CAPAs.
• New Product Development experience from initial concept to commercialization (Class III preferred).
• Experience with Risk Management and Design Control
• Proven expertise in usage of MS Office Suite including MS Project
• Basic understanding of statistical techniques
• Strong problem-solving, organizational, analytical, and critical thinking skills

Education/Experience:

• Bachelor's degree in engineering required.
• 2-4 years' experience required.

Trinus Corporation, a leading provider of technology solutions and services with over 25 years of experience, is a certified WBE/MBE/SBE/SDB firm accredited by WBENC, NMSDC, and SBA.

Our mission is to shape the future of work by aligning the right mix of people, process, technology, and innovation to efficiently meet our clients' business objectives.

At Trinus, we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements; they are about matching your skills and aspirations with the perfect fit.

To learn more about us, please visit our website href="