Mechanical Engineer

Role: Mechanical Quality Engineer Location: Valencia, CA 91355 Duration: 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. TheQuality Engineerwill 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 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 devices 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 techniquesMinimum 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 adaptivePreferred 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