Validation Engineer II

Alphatec Spine•Carlsbad, CA

13h•$90,000 - $110,000

About The Position

The Validation Engineer II is a mid-level role responsible for creating, planning, and executing software verification activities, and contributing to continuous improvement and validation processes. The Validation Engineer II operates under limited supervision and collaborates closely with R&D, Software Engineering, Quality Engineering, Mechanical Engineering, Marketing, and Regulatory to deliver innovative products to market in accordance with FDA, ISO, and IEC standards. The Validation Engineer II supports a broad range of software-enabled medical devices within a product suite that includes intraoperative neuromonitoring, surgical alignment, robotic navigation, and a cloud-based end-to-end platform, among others. The ideal candidate has experience validating software-based medical devices as well as strong technical, troubleshooting, documentation, and communication skills, and the ability to work seamlessly with cross-functional teams.

Requirements

Foundational understanding of FDA Quality System Regulations (21 CFR Part 820) & ISO 13485
Foundational understanding of IEC 62304 and IEC 60601 standards
Foundational understanding of ISO 14971 risk management requirements
Familiarity with defect tracking and test management tools (e.g., Jira, Polarion)
Working knowledge of test method qualification methods (Gage R&R, Attribute Agreement Analysis) and competency using desktop lab equipment (function generators, oscilloscopes, etc.)
Basic to working knowledge of probability and statistics concepts, and design of experiments (DoE)
Experience supporting Design History File (DHF) documentation and Change Order routing
Exposure to or experience supporting regulatory submissions such as 510(k)s
Demonstrated organizational and time-management skills to support cross-functional project activities
Ability to communicate technical concepts effectively with internal stakeholders and cross-functional team members
Detail-oriented, deadline-driven, and able to work collaboratively in a team environment
Bachelor’s or master’s degree in biomedical engineering or related field
2-8 years of experience in V&V or systems engineering for medical devices, or other regulated industries
For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

Nice To Haves

ASQ CSQE or CQE preferred.

Responsibilities

Leads verification and validation activities for assigned projects, ensuring quality, timeline, and compliance expectations are met while working alongside cross-functional teams.
Defines verification strategies for new product development, authoring high-quality test plans and protocols.
Supports continuous improvement of V&V practices by identifying inefficiencies, implementing process improvements, and participating in cross-functional problem-solving.
Creates and reviews design control documentation, ensuring requirements, test plans and protocols, test reports, and traceability meet FDA and internal quality standards.
Designs, develops, and qualifies manual and automated system-level test methods.
Performs validation of non–medical-device software tools and supporting systems as required, ensuring appropriate rigor and documentation.
Supports risk management activities in accordance with ISO 14971 by contributing to hazard analysis, risk controls, and verification of risk mitigations.
Seeks guidance from and collaborates with senior validation engineers; may informally assist with onboarding or knowledge sharing for newer team members.
Maintains regular and consistent attendance at the primary worksite.
Other duties as assigned.