Job DescriptionJob Summary:Responsible for creating test methods, work instructions, training and mentoring technicians who work on investigation of return and not-return products. The QE will review result of investigations completed by others for accuracy, completeness and compliance to SOPs/WIs. The results of investigations can be used to escalate product issues in collaboration with other Post Market functions, R&D, Design Assurance, Operations, Supplier Management, and Medical Safety.
Responsibilities will include:
- Understanding failure modes and approving product analysis for return and non-return complaints related to mechanical medical devices performed by technicians
- Coordinating, training and supervising failure investigation activities for lab technicians
- Support integration of new products into CIS lab by creating/validating test methods and test instructions
- Creating and presenting slides for SER/CRB
- Collaborating with other Post Market (CCC/CMC) teams, R&D, Design Assurance, Manufacturing, Supplier to help determine root cause of complaints
- Monitoring product performance and escalating any non-conformance issues with returned device.
- Creating, releasing new WI/SOPs in document control system
- Initiating and owning non-conformance investigations
- Training technicians to find root cause of complaints through sound failure analysis techniques
Minimum Qualifications:
- Bachelor's degree in Mechanical Engineering with 2+ years of relevant experience ***Bachelor's degree can be in electromechanical/electrical but the candidate needs to have hands-on experience in failure analysis.
- Demonstrated problem-solving & failure analysis capabilities of mechanical systems/components
- Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
- Great written/verbal communication skills and ability to collaborate with other teams
- Ability to successfully multi-task and be adaptive
Preferred Qualifications:
- Masters degree in Mechanical Engineering with at least 1 year experience in similar role
- Ability to understand system level functionalities, to devise and validate test methods for failure analysis of systems/components
- Experience in Medical Device industry
- Familiarity with Post Market requirements and systems
- Familiarity complaint systems used for medical devices
- Experience with using SAP and PowerBI
Other Details:
Schedule: 08:00:AM - 04:30:PM
Work Setup: Onsite in Valencia, CA
Contract Length: 12 Months (5/25/2026 - 5/25/2027) and Possible Extension
