Position: NPD Quality Engineer, Req#: 10614-1

Location: Irvine, CA (100% Onsite)

Duration: 6+ Months Contract

Job Description:

This NPD Quality Engineer will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product design, internal and external device manufacturing, and device distribution. Furthermore, this Quality Engineer will coordinate and perform complaint investigations as well as DMR/DHR changes in support of clinical inventory.

Education and Experience (Required Qualifications):

• Bachelor’s degree in Engineering with a minimum of (4) 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

Additional Skills (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 Excel, Power Point, and WordProject
• Experience with using Adobe Acrobat
• Basic understanding of statistical techniques
• Strong problem-solving, organizational, analytical, and critical thinking skills
• Self-project management and tracking of deliverables with various participants and stakeholders
• Strong communication skills across various cross-functional groups and levels

Job Responsibilities:

• 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