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ATEC Spine · 9 hours ago

Validation Engineer II

Carlsbad, CA

Full-time

Onsite

Mid, Senior Level

$90K/yr - $110K/yr

2+ years exp

ATEC Spine is a company focused on innovative medical devices, and they are seeking a Validation Engineer II. This role is responsible for leading software verification activities and ensuring compliance with FDA and ISO standards while collaborating with cross-functional teams.

Health CareMedical DeviceProduct Design

No H1B

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

Qualification

FDA Quality System RegulationsISO 13485IEC 62304IEC 60601ISO 14971JiraPolarionTest method qualificationProbabilityStatisticsDesign History FileRegulatory submissionsASQ CSQECQEOrganizational skillsTime-management skillsCommunication skillsDetail-orientedTeam collaboration

Required

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