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Edwards Lifesciences Senior Engineer, Failure Analysis in Irvine, California

The Failure Analysis Engineer will contribute to the investigation and analysis of failures in disposable medical equipment as a lead investigator on a cross functional team. You will serve as the subject matter expert to lead, investigate and correct failure modes of disposable medical products from the Critical Care product portfolio.

The Failure Analysis Engineer will report into the Critical Care Global Supply Chain Operations organization. You will serve as a key role in pro-actively identifying issues in the field and will work closely with the cross-functional groups to ensure that the issues are robustly investigated using core engineering principles. You will be responsible for ensuring that root causes are correctively identified experimentally, proposing corrective actions that will eliminate failure modes, ensuring corrective action compliance with Quality and Regulatory requirements, and documenting your results in technical summaries. Additionally, the Failure Analysis engineer will work with Complaint Engineers to proactively identify any emerging trends and provide technical council to management about these trends and their risk to the business.

Responsibilities:

  • Develop strategies and lead the technical management efforts to identify and correct issues relating to device failures in the field.

  • Conduct root cause mechanical failure analysis on medical equipment and apply analysis findings to propose corrective actions and to assess risk to patients and associated production lines.

  • Effectively communicate and influence the outcome of a failure investigations in a high energy, cross-functional team and multi-site environment that includes R&D, Regulatory, Quality, Procurement, Supply Chain, Supplier Quality/Development and Manufacturing/Operations.

  • Communicate failure analysis findings coherently and accurately to senior management and provide technical input to their decision-making processes. Communicate findings in thoroughly documented reports. Create and maintain a searchable database of technical summaries related to failure investigations.

  • Identify and implement new methods for tracking failure trends in the field by collaborating with Quality Engineering.

  • Work closely with Manufacturing and Quality Engineering to propose and implement corrective actions.

  • Work closely with complaint investigators to address field return units send back for suspected malfunction.

  • Use statistical techniques, such as Design of Experiment (DOE), to provide statistical evidence of root cause analysis conclusions.

  • Understand the application of various failure analysis techniques and their relative advantages.

  • Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) on existing product lines to qualify and investigate manufacturing issues, analyze results, make recommendations, and develop reports.

  • Train, coach, and guide lower level employees on more complex procedures and root cause analysis methodology.

  • Be the subject matter expert in key disciplines related to the manufacture of Class II and III medical devices.

  • Perform other duties and responsibilities as assigned.

Qualifications:

  • Bachelor’s degree in engineering with a minimum of 4 years of experience or Master’s degree with 3 years of experience in the medical device industry with key technologies and processes related to the assembly and manufacture of Class II or III cardiovascular devices.

  • Bachelor's degree in engineering discipline is required, preferably Mechanical, Electrical, Materials, or Biomedical Engineering.

  • Experience in leading and serving in a technical role for Failure Analysis or Reliability Engineering.

Preferred Qualifications:

  • Demonstrated use of root cause methodologies and applied statistics / six-sigma methodologies.

  • Extensive understanding of materials, processes and equipment used in disposable medical equipment (e.g. Plastics, Adhesive bonding (Solvent and UV), Molding, Extrusion, Welding, Sterilization, Soldering, PCBA manufacturing).

  • Knowledge of cGMP, EHS guidelines, FDA guidelines, Supplier Quality, Test Method Validations and Process Validation (IQ/OQ/PQ).

  • Proven expertise in usage of MS Office Suite; CAD experience preferred.

  • Excellent documentation and communication skills and interpersonal relationship skills including conflict management skills.

  • Ability to articulate and translate technical information to all levels of the organizations.

  • Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering, especially materials science, plastics, manufacturing engineering, and failure modes.

  • Advanced problem-solving, organizational, analytical and critical thinking skills.

  • Strong leadership skills and ability to influence change. Ability to manage competing priorities in a fast-paced environment.

  • Strict attention to detail and the ability to deal with and assess conflicting information.

  • Ability to interact professionally with all organizational levels.

  • Must be able to work in a team environment, including frequent inter-organizational and contacts.

  • Represents organization in providing solutions to difficult technical issues relating to failure modes in the field.

  • Travel Approximately 30%.

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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.

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