What are the responsibilities and job description for the Quality Engineer II - Mechanical/Electromechanical Failure Analaysis position at Advantage Technical?
Quality Engineer II – Mechanical/Electromechanical Failure Analysis
Pay Rate: $51.00/hr Schedule: 8:00 AM – 4:30 PM
1 Year Contract Initial - Possible extension
Location: Onsite – Valencia, CA
Work Authorization: Must be authorized to work in the U.S. (no sponsorship)
Role Overview
This role supports post‑market product investigations for mechanical and electromechanical medical devices. The Quality Engineer will develop test methods, mentor technicians, and ensure investigations meet SOP/WI requirements. Findings may drive escalations and cross‑functional collaboration with R&D, Design Assurance, Operations, Supplier Management, and Medical Safety.
Key Responsibilities
- Understand failure modes and approve product analysis for returned and non‑returned mechanical medical devices
- Coordinate, train, and supervise lab technicians performing failure investigations
- Develop and validate test methods and instructions for integrating new products into the CIS lab
- Create and present SER/CRB slide decks
- Collaborate with Post Market teams (CCC/CMC), R&D, Design Assurance, Manufacturing, and Supplier teams to determine root cause of complaints
- Monitor product performance and escalate non‑conformance issues
- Create and release new SOPs/WIs in the document control system
- Initiate and own non‑conformance investigations
- Train technicians in root‑cause analysis and sound failure analysis techniques
Minimum Qualifications
- Bachelor’s degree in Mechanical Engineering with 2 years of relevant experience
- Degree may also be in electromechanical or electrical engineering if the candidate has hands‑on failure analysis experience
- Demonstrated failure analysis and problem‑solving skills for mechanical systems/components
- Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook
- Strong written and verbal communication skills
- Ability to multitask and adapt to changing priorities
Preferred Qualifications
- Master’s degree in Mechanical Engineering with 1 year of similar experience
- Ability to understand system‑level functionality and develop/validate test methods
- Experience in the medical device industry
- Familiarity with post‑market complaint systems and requirements
- Experience using SAP and PowerBI
Salary : $51