Engineer II Product Analysis

Thornton Tomasetti; Los Angeles (CA); On-site; USD 82,000 - 141,000; Full time

Job summary

Abbott is seeking an Engineer II Product Analysis to perform failure analysis on explanted biomedical implant products. The role involves leading a team in Sylmar, CA, ensuring QA/QMS compliance and collaborating across cross-functional teams to identify root causes and implement investigative protocols.

The candidate will work onsite, applying analytical techniques and project management to deliver reliable failure investigations and improvements, with an emphasis on regulatory requirements and

Qualifications

• Bachelor's Degree in Engineering, Science, or closely related field.
• 3+ years of experience in failure analysis.
• Strong written and verbal communication and interpersonal skills.
• Ability to meet deadlines across multiple projects and work with all levels.
• Advanced computer skills and professional certifications welcomed.

Responsibilities

• Perform failure analysis on explanted biomedical implant products.
• Lead and coordinate a team of product support staff.
• Ensure compliance with FDA regulations and QMS/EMS requirements.
• Collaborate with Product Development, Engineering, Manufacturing, and Surveillance teams.
• Define test equipment needs to achieve quality objectives.
• Oversee day-to-day operations of product support areas for efficiency.

Skills

Failure analysis

Root cause analysis

Team leadership

Regulatory compliance

Technical communication

Education

Bachelor's degree in Engineering/Sciences

Tools

Spreadsheet

Word processing

Database management

Job description

JOB DESCRIPTION

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

JOB FAMILY: Operations Quality DIVISION: CRM Cardiac Rhythm Management LOCATION: United States > Sylmar : 15900 Valley View Court ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES:

• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
• Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

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