Product Analysis

MAIN PURPOSE OF ROLE - Summarize the main purpose of the role.

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 circuit analysis, performs device and component level failure analysis.

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.

• 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 Level Major/Field of Study

O r

Education Level

Bachelors Degree (± 16 years)

Biomedical Engineering preferred, or Engineering, Science, or closely related discipline.

☒ an equivalent combination of education and work experience

Experience/Background

No Experience 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. Personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments.