Validation Engineer II

Location: Carlsbad
Posted on: June 23, 2025

Job Description:

The Validation Engineer II is responsible for managing verification activities on complex projects within new product development and sustaining engineering. This role focuses on software and system-level validation and involves close collaboration with cross-functional teams to ensure product quality and regulatory compliance. The Validation Engineer II supports a broad range of software-enabled medical devices, working across multiple systems and technologies within a product suite that includes intraoperative neuromonitoring, surgical alignment, imaging analysis, and robotic navigation, among others. Essential Duties and Responsibilities • Independently develops, executes, and manages test plans and protocols for assigned projects, ensuring alignment with product requirements, regulatory expectations, and project timelines • Supports improvements in validation processes and contributes to the development and refinement of test methods, including both manual and automated approaches. • Leads test method execution and qualification efforts on their assigned products, identifying issues and driving resolution in collaboration with cross-functional teams. • Contributes to risk management activities, supporting hazard identification, mitigation verification, and documentation in accordance with ISO 14971. • Authors and maintains Computer Systems Validation (CSV) documentation per FDA guidance, including requirements specifications, validation plans, test scripts, and summary reports. • Serves as a resource for junior engineers, providing informal mentorship and guidance on test development and best practices. • Supports audit readiness by maintaining thorough and accurate documentation. • Maintains regular and consistent attendance at the designated worksite and fulfills project responsibilities with limited supervision. Requirements The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Working knowledge of FDA Quality System Regulations (21 CFR Part 820) & ISO 13485 • Familiarity with IEC 62304 and IEC 60601 requirements • Familiarity with ISO 14971 requirements • Experience with test case management software and ALM software (e.g. Polarion, Jira) • Awareness of ANSI C63:27 requirements for wireless coexistence a plus • Working knowledge of test method qualification methods (Gage R&R, Attribute Agreement Analysis) including competency using desktop lab equipment (function generators, oscilloscopes, etc) • Working knowledge of Statistical Process Control (SPC), Design of Experiments (DOE), probability and statistics preferred • Experience supporting testing and validation of medical products through full life cycle including writing protocols, reports, and procedures • Experience with project management and the ability to drive predictable outcomes from complex projects. • Strong attention to detail, effective communication skills, and ability to work collaboratively in cross-functional teams Education and Experience • Bachelor’s degree in engineering or related field, with 2-8 years of medical device experience. CERTIFICATES, LICENSES, REGISTRATIONS • ASQ CSQE or CQE preferred.

Keywords: , San Diego , Validation Engineer II, Engineering , Carlsbad, California