Job Title: Validation Engineer
Location: San Jose, CA, USA
Duration: long Term

Position Overview:

We are seeking a Validation Engineer with 4-5 years of experience in medical device manufacturing, specifically in process and equipment qualification. The candidate will have hands-on experience with test method validation, clean room environments, and a strong understanding of FDA and ISO regulations. This role involves developing, validating, and executing test methods, as well as supporting engineering builds and change management processes.

Key Responsibilities:

• Perform Process and Equipment Qualification (IQ/OQ/PQ) in compliance with industry standards.
• Develop and validate test methods for Design Verification and Validation (V&V), Process Validation, and Production.
• Conduct Gauge R&R Studies, Attribute Analysis Studies, and other related validation tasks.
• Author and release new test methods, as well as update or redline existing test methods.
• Work on engineering change orders and collaborate with teams for change management.
• Define equipment requirements and draft detailed equipment specifications.
• Identify and manage critical process parameters related to equipment.
• Ensure compliance with FDA Quality System Regulation (21 CFR 820) and ISO 13485 standards.

Qualifications:

• Bachelor's or Master's degree in Mechanical Engineering or related field.
• 3+ years of experience in medical device manufacturing.
• Experience working in a clean room environment.
• Proficiency with Test Method Validation and Measurement System Analysis (preferred).
• Strong knowledge of Microsoft Excel and statistical software (Minitab preferred).
• Experience with 3D CAD Software (SolidWorks).
• Familiarity with engineering change management software and engineering change orders.
• Competence with Microsoft Office Suite (Word, Excel, PowerPoint).