Mechanical Engineer

Role: Mechanical Quality EngineerLocation: Valencia, CA 91355Duration: 12 Months (Possible extension/Hire)Job Description:Responsible for creating test methods, work instructions, training and mentoring technicians who work on investigation of return and not-return products.The Quality Engineer 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.Your Responsibilities Will Include:Understanding failure modes and approving product analysis for return and non-return complaints related to mechanical medical devices performed by techniciansCoordinating, training and supervising failure investigation activities for lab techniciansSupport integration of new products into CIS lab by creating/validating test methods and test instructionsCreating and presenting slides for SER/CRBCollaborating with other Post Market (CCC/CMC) teams, R&D, Design Assurance, Manufacturing, Supplier to help determine root cause of complaintsMonitoring product performance and escalating any non-conformance issues with returned devicesCreating, releasing new WI/SOPs in document control systemInitiating and owning non-conformance investigationsTraining technicians to find root cause of complaints through sound failure analysis techniquesMinimum Qualifications:Bachelor's degree in Mechanical Engineering with 2+ years of relevant experienceBachelor'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/componentsProficient with Microsoft Office tools including Word, Excel, PowerPoint, and OutlookGreat written/verbal communication skills and ability to collaborate with other teamsAbility to successfully multi-task and be adaptivePreferred Qualifications:Masters degree in Mechanical Engineering with at least 1 year experience in similar roleAbility to understand system level functionalities, to devise and validate test methods for failure analysis of systems/componentsExperience in Medical Device industryFamiliarity with Post Market requirements and systemsFamiliarity complaint systems used for medical devicesExperience with using SAP and PowerBI

Created: 2026-05-09