Quality Engineer II — Medical Device (Onsite — Valencia, CA) Possible Contract Extension

Job Summary:

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

• Experienc