Validation Engineer: CIP & Process Improvement in Medical Devices

Katalyst CRO; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a Validation Engineer to support product validation and engineering in a regulated medical device environment. You will lead CIP initiatives, support process validation, and ensure compliance with regulatory standards while collaborating with internal teams and external suppliers to improve product performance and reduce costs.

The role focuses on validation of systems and processes, including product electrical design and functionality, with oversight of CIP

Qualifications

• Bachelor's degree in Electrical, Mechanical, Software or related engineering field.
• 3–5 years of relevant experience in validation/engineering in a regulated industry.
• Experience in medical device or similarly regulated environments preferred.
• Strong understanding of validation processes, process engineering, and engineering documentation.

Responsibilities

• Lead CIP (Continuous Improvement) projects with cross-functional teams and external suppliers.
• Perform CIP calculations including supplier quotations and cost–benefit analyses.
• Develop and manage project budgets for feasibility studies, capital equipment, validation costs, and testing.
• Create detailed project plans using Microsoft Project and prepare presentations with PowerPoint.
• Demonstrate understanding of product electrical design, system architecture and functional performance.
• Lead design changes, substitutions, and supplier transitions to achieve cost savings.
• Develop strategies to meet CIP targets and drive continuous improvement.
• Conduct engineering testing, develop test protocols, prepare test reports, and participate in design reviews.
• Oversee project execution including timelines, dependencies and task coordination.
• Identify electrical test methods and align requirements with R&D teams.

Skills

Continuous Improvement

Validation engineering

Project management

Supplier coordination

Electrical design understanding

Test protocol development

Regulatory compliance

Education

Bachelor's degree in Electrical/Mechanical/Software Engineering

Tools

Microsoft Project

PowerPoint

Job description

Katalyst CRO is seeking a Validation Engineer to support product validation and engineering in a regulated medical device environment. You will lead CIP initiatives, support process validation, and ensure compliance with regulatory standards while collaborating with internal teams and external suppliers to improve product performance and reduce costs.

The role focuses on validation of systems and processes, including product electrical design and functionality, with oversight of CIP