Bachelor's degree in Mechanical Engineering or related field with 2+ years of hands-on failure analysis experience.
Demonstrated problem-solving and failure analysis capabilities with mechanical systems/components.
Proficient in Microsoft Office, including Word, Excel, PowerPoint, and Outlook.
Strong written and verbal communication skills with a collaborative mindset.
Ability to multi-task effectively and adapt to changing priorities.
Responsibilities
Understand and approve product analysis for mechanical device complaints.
Coordinate, train, and supervise lab technicians in failure investigation activities.
Support new product integration by creating and validating test methods and instructions.
Create and present slides for SER/CRB meetings.
Collaborate with cross-functional teams to determine root cause of product complaints.
Monitor product performance and escalate non-conformance issues.
Initiate and own non-conformance investigations, ensuring thorough analysis.
Benefits
Opportunity to train and mentor technicians in advanced failure analysis techniques.
Engage in cross-team collaborations enhancing learning from various functions.
Work in a dynamic environment focused on the medical devices industry.
Involvement in developing and validating innovative test methods for new products.
Full Job Description
Job Description Job 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
