Engineer II

3 weeks ago

Irvine, United States Planet Pharma Full time

MUST have skills:

-Proficient with the Microsoft office suite

-Experience with medical device complaint investigations (CAPA's, NCR's, and Root-Cause Analysis)

-Functional, physical, and visual testing of medical device equipment in a laboratory setting


This position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is responsible for leading and performing critical engineering investigations on globally reported complaints for returned/non-returned devices. The role is not remote and will required presence on campus.


Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures for device investigation and risk assessments of reported complaints from the field.


Key Responsibilities: Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports. Perform hands-on device investigation using visual, dimensional, and test equipment to determine root cause Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed. Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) - CAPAs, SCARs, as determination by investigation. Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device related issues. Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).


Education and Experience: Bachelor's Degree or equivalent in Engineering or Scientific field, 2 years experience related work experience required; or Master's Degree or equivalent in Engineering or Scientific field, 1 year experience including either industry or industry/education required. Experience in medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred. Experience in complaint investigations, root cause analysis, and the associated risk assessments preferred.


Additional Skills: Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills Basic understanding of statistical techniques Previous experience working with lab/industrial equipment required Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering Solid problem-solving, organizational, analytical and critical thinking skills Solid understanding of processes and equipment used in assigned work Knowledge of and adherence to Quality systems Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast-paced environment Must be able to work in a team environment, including the ability to manage project stakeholders Ability to build productive internal/external working relationships

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