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Edwards Lifesciences Quality Engineer II - Critical Care in Irvine, California

Edwards' innovative Critical Care organization is seeking Complaint Quality Engineer II to perform failure investigations and lead engineering evaluation for customer complaints for Critical Care's products. The Quality Engineer will apply knowledge of technical principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to facilitate continuous improvement of product quality and reducing product complaints. We are looking for a strong engineer with solid technical expertise and leadership skills, who enjoys working in a fast-paced and rapidly growing environment.

Key Responsibilities:

  • Investigate complex product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.

  • Participate in and own escalation tasks and activities, including Project Risk Assessments (PRAs) and Corrective/Preventive action(s) (CAPAs) as determination by investigation.

  • Identify and report key complaint metrics per device category and collaborate with applicable Clinicians, Manufacturing Engineering, R&D, sustaining engineering teams to investigate and resolve device related issues.

  • Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.

  • Update and maintain technical content of risk management files.

  • Support development of moderately complex experiments and tests (including writing and executing protocols) to investigate issues and improve products and manufacturing methods based on engineering principles; analyze results, make recommendations, and develop reports

  • Other incidental duties assigned by Leadership

Education and Minimum Requirements:

  • Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering or related engineering field with 3+ years of relevant industry experience in Quality Engineering or Quality Assurance; OR Master's Degree or equivalent and internship, senior projects, or thesis in Engineering field including relevant industry experience or combined industry/education experience

  • Complaints investigations experience within the life science industry and working in an FDA regulated environment

Preferred Qualifications:

  • Substantial understanding and knowledge of principles, theories, and concepts relevant to EMI/EMC hardware and software knowledge within circuitry level (PCB level ) as well as system.

  • Knowledge of regulatory requirements, e.g. FDA, IEC, CE, ISO, IEEE

Additional Talent and Expectations:

  • Experience in conducting root cause investigation and prepare reports, for negative trends of process or product failures or critical characteristics not being met.

  • Complaints investigation experience and/or hands-on experience with device investigations

  • Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

  • Strong problem-solving, organizational, analytical and critical thinking skills (strict attention to detail)

  • Demonstrated experience by applying risk management tools (FMEA) to solve complex problems

  • Basic understanding of statistical techniques

  • Ability to interact professionally with all organizational levels and manage competing priorities in a fast-paced environment

  • Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.