Senior Test Method Validation Engineer (Onsite)

Abbott; Santa Clara (CA); In loco; USD 120.000 - 155.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Descrizione del lavoro

Abbott in Santa Clara, CA seeks a Senior Test Method Validation Engineer IV to join a product development team advancing transcatheter valve technologies. The role focuses on testing, data analysis, and validation of test methods, with responsibility for design concept generation and risk assessment.

You will work onsite in a fast-paced environment, coordinating with multiple departments and vendors to ensure regulatory compliance and timely design advancement.

Competenze

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related field.
• 7+ years of design, testing, manufacturing or engineering support experience.
• Experience in a fast-paced, regulated environment and cross-functional teams.

Mansioni

• Lead test method validation protocol development, execution, and reporting.
• Involve in requirements development to influence design goals.
• Develop test methods and models; perform data analysis to meet goals.
• Generate design concepts to satisfy target goals under guidance.
• Identify issues, perform root-cause analysis, and support risk management documentation.
• Collaborate with internal departments and external vendors for prototyping.
• Comply with FDA, ISO and Abbott quality requirements and maintain records.

Conoscenze

Verbal & written communication

Cross-functional collaboration

Attention to detail

Project prioritization

Formazione

Bachelor's degree in Mechanical Engineering or Biomedical Engineering

Strumenti

SolidWorks

Windchill

Descrizione del lavoro

Abbott in Santa Clara, CA seeks a Senior Test Method Validation Engineer IV to join a product development team advancing transcatheter valve technologies. The role focuses on testing, data analysis, and validation of test methods, with responsibility for design concept generation and risk assessment.

You will work onsite in a fast-paced environment, coordinating with multiple departments and vendors to ensure regulatory compliance and timely design advancement.