Validation Engineer III
Company: Alphatec Holdings, Inc.
Location: Carlsbad
Posted on: October 29, 2025
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Job Description:
The Validation Engineer III is an advanced role responsible for
leading significant validation projects and contributing to
organizational process improvements. Under minimal supervision, the
Validation Engineer III will work closely with Quality Engineering
(QE), Research & Development (R&D), Marketing, and Regulatory
to bring products to market while ensuring compliance to applicable
standards and regulations. Essential Duties and Responsibilities •
Leads design verification & validation activities for complex
projects, ensuring deliverables meet quality, timeline, and
compliance requirements, while providing clear direction to
cross-functional teams. • Defines and executes comprehensive design
verification and validation strategies for new product development,
including authoring test plans and protocols, with an emphasis on
developing processes in uncharted or ambiguous areas. • Drives
innovation in verification & validation methodologies, developing
advanced test methods, optimizing validation processes, and
facilitating cross-functional problem resolution to achieve project
goals. • Manual and automated system test method development and
qualification. • Represents Quality Engineering when collaborating
with designated personnel to develop various design controls
documents per FDA guidance (General Principles of Software
Validation), including but not limited to Requirements
Specifications, Validation/Test Plan, Testing, Integration Test
Scripts, Operational/System Test Scripts, and Validation Summary
Reports. • Contributes to Risk Management efforts in accordance
with ISO 14971. • Provides informal oversight and mentoring to
less-experienced validation engineers. • Maintains regular and
consistent attendance at the normal worksite. • Other duties as
assigned. Requirements The requirements listed below are
representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions. • Proficient in
FDA Quality System Regulations (21 CFR Part 820) & (ISO 13485:2016)
• Proficient in IEC 62304, IEC 60601 requirements • Proficient in
ISO 14971 requirements. • Understanding of ANSI C63:27 American
National Standard for Evaluation of Wireless Coexistence
requirements • Experience with Test Case management software and
ALM software (Polarion) is a plus. • Working knowledge of test
method qualification methods (Gage R&R, Attribute Agreement
Analysis) including competency using desktop lab equipment
(function generators, oscilloscopes, etc) • Working knowledge of
Statistical Process Control (SPC), Design of Experiments (DOE), and
probability and statistics preferred. • Prior successful testing
and validation of medical products through full life cycle
including writing protocols, reports, and procedures required •
Demonstrates comprehensive knowledge of project management
techniques to ensure predictability of complex cross-functional
projects. • Ability to demonstrate technical expertise and
communicate with internal and external customers and executive
management. • Must be deadline-oriented and detail-oriented, an
effective communicator, and able to work within a team environment.
Education and Experience • Bachelor’s degree in engineering or
related field, with a minimum of six (6) years of medical device
experience; OR Master’s degree in engineering or related field,
with a minimum of five (5) years of medical device experience.
Keywords: Alphatec Holdings, Inc., Carlsbad , Validation Engineer III, Engineering , Carlsbad, California
