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ATEC Spine · 19 hours ago

Senior Validation Engineer

Carlsbad, CA

Full-time

Onsite

Senior Level, Lead/Staff

$130K/yr - $160K/yr

8+ years exp

ATEC Spine is a company focused on delivering innovative medical devices to the market. The Senior Validation Engineer is responsible for leading verification and validation activities for complex projects while collaborating with cross-functional teams to ensure compliance with FDA and ISO standards.

Health CareMedical DeviceProduct Design

No H1B

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

Qualification

FDA Quality System RegulationsISO 13485IEC 62304IEC 60601ISO 14971JiraPolarionStatistical Process ControlDesign of ExperimentsProject managementTroubleshooting skillsCommunication skillsDocumentation skillsTeam collaboration

Required

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