Quality Engineer – Electro‑Mechanical Failure Analysis (Lab‑Based Role)
Overview
The candidate will be working in the lab, so the manager is seeking someone with an electrical engineering background who is experienced with evaluating electro‑mechanical failures in device components, ideally within medical devices. Candidate must have an understanding of RF communication scheme/concepts.
This role is responsible for creating test methods, work instructions, training and mentoring technicians who work on investigation of return and non‑return products. The QE will review results of investigations completed by others for accuracy, completeness, and compliance to SOPs/WIs. Investigation outcomes may be used to escalate product issues in collaboration with Post Market functions, R&D, Design Assurance, Operations, Supplier Management, and Medical Safety. The QE will also create monitoring IDs to assess product performance and investigate performance changes using data analysis tools to find cause.
Responsibilities
Leadership & Technical Oversight
- Providing leadership role on championing departmental or cross‑functional engineering initiatives.
- Understanding failure modes and approving product analysis for return and non‑return complaints related to electro‑mechanical devices performed by technicians.
- Coordinating, training, and supervising failure investigation activities for lab technicians.
Test Method Development & Integration
- Support integration of new products into CIS lab by creating/validating test methods and test instructions.
- Creating and presenting slides for SER/CRB.
Cross‑Functional Collaboration
- Collaborating with Post Market (CCC/CMC) teams, R&D, Design Assurance, Manufacturing, and Supplier teams to help determine root cause of complaints.
- Monitoring product performance and escalating any non‑conformance issues with returned devices.
Data Analysis & Documentation
- Creating and maintaining product performance trends based on UPN and code groupings.
- Investigating trend excursions by performing data analysis to find cause.
- Creating and releasing new WI/SOPs in the document control system.
- Initiating and owning non‑conformance investigations.
Training & Mentorship
- Training technicians to find root cause of complaints through sound failure analysis techniques.
Minimum Qualifications
- Bachelor’s degree in Electrical Engineering with 4+ years of relevant experience.
- Demonstrated problem‑solving and failure analysis capabilities of electronics systems/components, including those with RF communication.
- 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.
- Understanding of RF communication scheme/concepts.
- Requires working in San Diego for a few months.
Preferred Qualifications
- Master’s degree in Electrical Engineering with 2–3 years of experience in a similar role.
- Ability to understand system‑level functionalities to devise and validate test methods for failure analysis of systems/components.
- Experience in the medical device industry.
- Familiarity with Post Market requirements and systems.