Senior Validation Engineer

Alphatec Spine•Carlsbad, CA

51d•$130,000 - $160,000

About The Position

The Sr. Validation Engineer is an advanced role responsible for creating, planning, and executing complex software verification activities, and contributing to continuous improvement and validation processes. The Sr. Validation Engineer 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 ideal candidate has substantial experience validating software-based medical devices, including years dedicated to navigation and robotics technology, as well as strong technical, troubleshooting, documentation, and communication skills, and the ability to work seamlessly with cross-functional teams.

Requirements

Understanding of FDA Quality System Regulations (21 CFR Part 820) & ISO 13485
Understanding of IEC 62304 and IEC 60601 standards
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.)
Working knowledge of Statistical Process Control (SPC), Design of Experiments (DOE), and probability/statistics concepts
Background supporting regulatory submissions such as 510(k)s
Strong project management skills to coordinate complex, cross-functional projects
Ability to communicate technical concepts effectively with internal and external stakeholders, including executive management
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.
8+ years of experience in V&V or Systems Engineering for medical devices, or other regulated industries.

Nice To Haves

ASQ CSQE or CQE preferred.
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).

Responsibilities

Leads verification and validation activities for complex projects, ensuring quality, timeline, and compliance expectations are met while guiding cross-functional teams.
Defines verification strategies for new product development, authoring high-quality test plans and protocols - particularly in areas with limited precedent or high ambiguity.
Improves V&V practices by introducing improved methodologies, optimizing processes, and facilitating cross-functional problem-solving to support project objectives.
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.
Provides informal mentorship and technical guidance to less experienced validation engineers.
Maintains regular and consistent attendance at the primary worksite.
Other duties as assigned.