Role: Senior R&D Engineer

Location: Irvine, CA – 92614

Key Responsibilities:

• Provide expertise in Quality Assurance, Design Controls, Risk Management, Manufacturing Controls, and Statistical Techniques for NPD programs.
• Investigate and resolve complex product quality and compliance issues from the field, conduct root cause analysis, and document findings.
• Manage change control activities to enable rapid innovation and product development.
• Support design and development activities, including feasibility testing, engineering studies, and design reviews.
• Participate in escalation tasks and Project Risk Assessments (PRA).
• Lead or support test method development and validation for Design Verification testing and manufacturing inspections.
• Collaborate with R&D and Manufacturing teams to ensure successful product launches.
• Develop and execute experiments and validation protocols to improve and optimize products and manufacturing processes.
• Maintain and update Risk Management files to ensure compliance with regulatory standards.
• Create and refine training materials and work instructions for seamless production knowledge transfer.
• Provide guidance to technicians, assign tasks, oversee testing, and offer feedback.
• Perform other duties as assigned by leadership.
• Travel: Up to 10% domestic and international travel may be required.

Required Qualifications:

• Bachelor’s degree in Engineering with at least 4 years of experience in NPD, Quality Engineering, R&D, and/or Manufacturing OR
• Master’s degree in Engineering or a Scientific field with relevant internship, senior projects, or thesis experience.
• Experience working in a highly regulated industry.

Preferred Qualifications:

• Experience in medical devices (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related industry.
• Knowledge of Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process Validation.
• Experience conducting root cause analysis for complaints, NCRs, and CAPAs.
• New Product Development (NPD) experience from concept to commercialization (Class III devices preferred).
• Hands-on experience in Risk Management and Design Control.
• Proficiency in MS Office Suite (Excel, PowerPoint, Word, Project) and Adobe Acrobat.