Quality Engineer III

Description:


**The candidate ill be working in the lab, non-returner is seeking someone with a structural engineering background who is experienced with evaluating, electro-mechanical failures in device components, ideally within medical devices. Candidate has have an understanding of RF communication scheme/concepts.



About This Role:
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 with 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. He/She will be responsible for creating monitoring IDs to assess thee product performance and investigate performance changes using data analysis tools to find cause.


Your Responsibilities Will Include:
• Providing leadership role on championing departmental or cross-functional engineering initiatives
• Understanding failure modes and approving product analysis for return and nonand -return complaints related tthe o electro-mechanical devices performed by technicians
• Coordinating, training and supervising failure investigation activities for lab technicians
pport integration of new products into CIS lab by creating/validating test methods and test instructions
• Creating and presthe enting slides f andr SER/CRB
• Collaborating wthe ith other Post Market (CCC/CMC) teams, R&D, Design Assurance, Manufacturing, Supplier to help determine rootthe cause of complaints
• Monitoring product performance and escalating any non-conformance issues with returned devices
• Creating and maintaining of product performance trends based on UPN and code groupings.
• Investigating trend excursions by doing data analysis to find cause
• Creating, releasing new WI/SOPs in document control system
• Initiating and owning non-conformance inve,stigations
• Training technicians to find root cause of complaints through sound failure analysis techniques

What We're Looking for in You:
Minimum Qualificatimultitasklor's degree in Electrical Engineering with 4+ years of relevant experience
• Demonstrated problem-solving & failure analysis capabilities of el Master'scs systems/components, including those with RF comof munication
• Pra oficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
• Great written/verbal communication skills and ability to collaborate with othe ther teams
• Ability to successfully multi-task and be adaptive
• Understanding of RF communication scheme/concepts
• Requires working in San Diego for a few months



Preferred Qualifications
• Masters degree in Electrical Engineering with 2-3 years 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