Engineer II Product Analysis

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. 

We are seeking an experienced, high caliber Engineer II, Product Analysis for our Sylmar, CA location.

Perform failure analysis on explanted biomedical implant products and provide technical expertise to the Product Analysis Laboratory. Analyze product failures, develop and implement investigative protocols to identify root causes, and conduct technical evaluations to support quality and reliability objectives. Additionally, supervise and develop operations support staff responsible for product intake, documentation, tracking, and preparation activities that enable efficient laboratory operations.

• Supervises and develops a team of operations support staff, including hiring, training, coaching, performance management, and workload prioritization to support laboratory operations and departmental objectives.

• Perform failure analysis on explanted long-term biomedical implant products.

• Work requires the application of theoretical principles, evaluation, ingenuity, and creative/analytical techniques to identify root cause failure mechanisms.

• Must be able to meet deadlines on multiple assignments and be able to operate in a diverse cross-functional team environment.

• Proactively identifies and removes process barriers and implements improvements to enhance the efficiency and effectiveness of laboratory operations and failure analysis activities.

• May serve as lead and assign work to less experienced personnel and serve as a mentor when assisting less experienced lab staff in solving more complex problems.

• Works cross functionally and collaboratively with Product Development, Engineering, Manufacturing, and Product Surveillance.

• Assists in defining test equipment requirements necessary to fulfill quality and reliability objectives.

• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

QUALIFICATIONS 

Qualifications

• Bachelors Degree (± 16 years) 
• Mechanical Engineering preferred, or Engineering, Science, or closely related discipline (OR) an equivalent combination of education and work experience 

Experience/Background 

Minimum 3 years of relevant work experience in performing failure analysis, with demonstrated leadership, mentoring, project leadership, or supervisory experience preferred. 

Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. 

A documented record of delivering reliability engineering information which adds value to management’s decision making process is required. 

Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. 

Must be able to handle multiple assignments. 

An advanced credential in relevant discipline/concentration. A relevant professional certification or designation. Previous experience in failure analysis and in the medical device industry is highly desirable. Academic or in-house courses in project management, Six-Sigma, leadership, Total Quality Management (TQM) and various technical applications as noted above are also desired.