Position: Sr. R&D Engineer - NPD Quality Engineer
Location: Irvine, CA 92614 (On-site)
Duration: 6+ Months (W2 Contract)
Shift: Monday to Friday, 8:00 AM - 5:00 PM (1-hour lunch break)
What You'll Do:
- Support Quality Assurance, Design Controls, Risk Management, and Manufacturing Controls for New Product Development (NPD) programs
- Investigate product quality issues from the field, perform root cause analysis, and provide actionable solutions
- Drive change control activities to support rapid product innovation and clinical inventory readiness
- Collaborate with R&D and Manufacturing teams to support design, verification, and validation processes
- Lead or support test method development/validation and participate in project risk assessments
- Develop experiments, analyze results, and generate reports to improve products and manufacturing processes
- Maintain risk management files and create production training and documentation materials
What We're Looking For:
- Bachelor's in Engineering with 4+ years of experience in NPD, Quality Engineering, R&D, or Manufacturing (or Master's with relevant projects/internships)
- Experience in highly regulated industries (medical device preferred)
- Proficiency in Design Controls, Risk Management, and CAPA processes
- Hands-on experience with test method validation, process validation, and technical documentation
- Proficient in MS Office, Adobe Acrobat, and basic statistical techniques
- Creative, hands-on problem solver with a "do-er" mentality - not just paperwork focused
- Ability to walk the lab floor and directly investigate device failures and recommend creative, compliant solutions