Validation Engineer IV

Job Title: Validation Engineer IV

Location: 3200 Lakeside Drive, Santa Clara, CA 95054

Duration: 6 Months

Work Arrangement: 100% Onsite

Position Overview

We are seeking a Senior Test Method Validation Engineer to join our team in Santa Clara, CA. In this role, you will be part of a product development team focused on delivering next generation transcatheter valve technologies to the global healthcare market.

The engineer will support test method development and validation activities, including testing, statistical analysis, and design collaboration to support product development and process improvement initiatives.

Key Responsibilities

• Lead test method validation protocol development, execution, statistical analysis, and reporting.
• Contribute to requirements development to influence product design goals.
• Support test method and model development for product evaluation.
• Perform testing and data analysis to support design and process development objectives.
• Under guidance, contribute to design concept generation to meet engineering requirements.
• Identify potential design or test method issues and perform root cause analysis.
• Collaborate with internal teams and external vendors to obtain prototype parts and fixtures.
• Apply knowledge of measurement system analysis, metrology, and Gage R&R.
• Support development of risk management documentation (DFMEA, UFMEA, PFMEA) as needed.
• Execute assigned tasks to support overall project and program goals.
• Gain working knowledge of quality and regulatory requirements including FDA and ISO standards.
• Ensure compliance with FDA regulations, company policies, operating procedures, and quality processes.
• Maintain strong collaboration and communication with cross-functional teams, vendors, and stakeholders.
• Perform other related duties as assigned.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• Minimum 5+ years of engineering experience in design, testing, manufacturing, or engineering support.
• Strong analytical and problem-solving abilities with attention to detail.
• Ability to work independently with structured guidance in a fast-paced environment.
• Excellent verbal and written communication skills with the ability to communicate effectively across organizational levels.
• Proven ability to collaborate with cross-functional teams and stakeholders.
• Strong organizational, prioritization, and follow-up skills.

Preferred Qualifications

• Experience in medical device or other regulated industries.
• Experience with SolidWorks or other CAD tools.
• Familiarity with electronic document control systems such as Windchill.
• Experience working within cross-functional teams in a geographically distributed, 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.