Engineer II Product Analysis

MAIN PURPOSE OF THE ROLE

The Engineer II Product Analysis will perform failure analysis on explanted biomedical implant product. Provide technical expertise to the Product Analysis Laboratory. Analyzes failures, develops and implements investigative protocols to identify root causes, performs device and component level failure analysis.
Supervise and coordinate a team of product support staff.

This role is ONSITE and is based out of SYLMAR, CA

MAIN RESPONSIBILITIES

• Perform failure analysis on explanted long term biomedical implant product.
• Work requires the application of theoretical principals, evaluation, ingenuity, and creative/analytical techniques to identify route cause failure mechanisms.
• Must be able to meet deadlines on multiple assignments and be able to operate in a diverse cross-functional team environment.
• Proactive in finding quality improvements related to Failure Analysis
• May serve as lead and assign work to less experienced personnel and serves 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.
• Aides in definition of test equipment as required to accomplish quality responsibilities.
• Oversees day-to-day operations of a variety of product support areas to ensure product support needs are met efficiently, reliably, and economically.
• 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

Education

Bachelors Degree (± 16 years) in Engineering, Science, or closely related discipline.

or

An equivalent combination of education and work experience

Experience/Background

• Minimum 3 years

Experience Details

• Relevant work experience in performing failure analysis.
• 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.
• Supervisory experience preferred

The base pay for this position is $81,500.00 – $141,300.00. In specific locations, the pay range may vary from the range posted.

• failure analysis
• biomedical implant product analysis
• root cause analysis
• device failure analysis
• component failure analysis
• technical expertise
• quality management systems
• environmental management systems
• fda regulations
• six sigma
• total quality management
• project management
• spreadsheet software
• presentation skills
• analytical skills
• supervisory skills