Test Method Validation Engineer IV

Abbott; Santa Clara (CA); On-site; USD 120,000 - 155,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Verbal & written communication

Cross-functional collaboration

Attention to detail

Project prioritization

Education

Bachelor's degree in Mechanical Engineering or Biomedical Engineering

Tools

SolidWorks

Windchill

Job description

Title: Test MethodValidation Engineer IV

Location: Santa Clara, California

Duration: 7 Months + Extension

100% Onsite

Summary:

We are recruiting for our next Senior Test Method Validation Engineer to join our team in our Santa Clara, CA location. In this role, you will be part of a product development team focused on delivering future transcatheter valve technologies to the global healthcare market. This role will potentially involve a range of responsibilities including but not limited to testing and data analysis, design concept generation, and test method development and validation.

Primary Responsibilities:

• Lead test method validation protocol development, execution, statistical analysis, and reports
• Involved in requirement development to influence design goals
• Involved in test method and model development
• Complete testing and data analysis to achieve design and process development goals
• Under guidance, generating design concepts to meet specific design goals
• Identify potential issues with designs and test methods, perform root cause analysis
• Work with internal departments and outside vendors to obtain prototype parts and fixtures
• Understanding of measurement system analysis, metrology, gage R&R
• Support development of risk management documentation (DFMEA, UFMEA, PFMEA) -Optional
• Execute activity in support of project goals
• Gain an understanding of the quality and regulatory requirements of Abbott, FDA and ISO regulations
• completion of assigned tasks
• 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
• Performs other related duties and responsibilities, on occasion, as assigned

Required Qualifications:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or related field
• 7+ years’ minimum experience designing, testing, manufacturing or other engineering support
• Experience working within a team and as an individual contributor in a fast-paced, changing environment
• Strong verbal and written communications with ability to effectively communicate to all levels of the organization
• Proficient in collaborating with project stakeholders (client and internal) and technical team members
• Multitasks, prioritizes and meets deadlines in timely manner
• Strong organizational and follow-up skills, as well as attention to detail

Preferred Qualifications:

• Medical device or regulated industry experience
• Solidworks or other CAD experience
• Worked with an electronic document control system (Windchill, etc.)
• Experience working with cross-functional teams in a geographically diverse, matrixed organization

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.