Alphatec Spine
medical devices
ValidationEngineerII
Neural analysis suggests this role is
optimal for Mid candidates.
“Validation Engineer II at Alphatec Spine. Skills: software verification, validation processes, test plans and protocols, design control documentation, risk management, FDA, ISO, IEC. creating, planning, and executing software verification activities. contributing to continuous improvement and validation processes”
What You'll Achieve.
deliver innovative products to market in accordance with FDA, ISO, and IEC standards; ensuring quality, timeline, and compliance expectations are met
Industry & Context.
participating in cross-functional problem-solving; troubleshooting skills
Maintains regular and consistent attendance at the primary worksite., Candidates must be authorized to work in the United States without the need for current or future employer sponsorship., 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).
What They're Looking For.
Must Have
Foundational understanding of FDA Quality System Regulations (21 CFR Part 820), Foundational understanding of ISO 13485, Foundational understanding of IEC 62304, Foundational understanding of IEC 60601 standards, Foundational understanding of ISO 14971 risk management requirements, Experience supporting Design History File (DHF) documentation, Experience supporting Change Order routing, Ability to communicate technical concepts effectively with internal stakeholders and cross-functional team members, Detail-oriented, Deadline-driven, Ability to work collaboratively in a team environment, 2-8 years of experience in V&V or systems engineering for medical devices, or other regulated industries
Nice to Have
ASQ CSQE or CQE preferred
What You'll Do.
and executing software verification activities
contributing to continuous improvement and validation processes
leading verification and validation activities for assigned projects
defining verification strategies for new product development
authoring high-quality test plans and protocols
supporting continuous improvement of V&V practices
creating and reviewing design control documentation
and qualifying manual and automated system-level test methods
performing validation of non–medical-device software tools and supporting systems
supporting risk management activities
How You'll Work.
Team & Collaboration
collaborates closely with R&D, Software Engineering, Quality Engineering, Mechanical Engineering, Marketing, and Regulatory; works alongside cross-functional teams; participating in cross-functional problem-solving; collaborates with senior validation; informally assist with onboarding or knowledge sharing for newer team members; ability to communicate technical concepts effectively with internal stakeholders and cross-functional team members; able to work collaboratively in a team environment
Communication Scope
ability to communicate technical concepts effectively with internal stakeholders and cross-functional team members
Process & Methodology
ensuring quality, timeline, and compliance expectations are met
Full Job Description
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. **Essential Duties and 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 ri
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