Validation Engineer II

Atec SpineCarlsbad, CA

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Overview

Schedule

Full-time

Career level

Senior-level

Benefits

Career Development

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 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.

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FAQs About Validation Engineer II Jobs at Atec Spine

What is the work location for this position at Atec Spine?

This job at Atec Spine is located in Carlsbad, CA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Atec Spine?

Employer has not shared pay details for this role.

What employment applies to this position at Atec Spine?

Atec Spine lists this role as a Full-time position.

What experience level is required for this role at Atec Spine?

Atec Spine is looking for a candidate with "Senior-level" experience level.

What benefits are offered by Atec Spine for this role?

Atec Spine offers Career Development for this position. Actual benefits may vary depending on the employer's policies and employment terms.

What is the process to apply for this position at Atec Spine?

You can apply for this role at Atec Spine either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.