Validation Engineer II

The Validation Engineer II is responsible for managing verification activities on complex projects within new product development and sustaining engineering. This role focuses on software and system-level validation and involves close collaboration with cross-functional teams to ensure product quality and regulatory compliance. The Validation Engineer II supports a broad range of software-enabled medical devices, working across multiple systems and technologies within a product suite that includes intraoperative neuromonitoring, surgical alignment, imaging analysis, and robotic navigation, among others.

Essential Duties and Responsibilities

• Independently develops, executes, and manages test plans and protocols for assigned projects, ensuring alignment with product requirements, regulatory expectations, and project timelines
• Supports improvements in validation processes and contributes to the development and refinement of test methods, including both manual and automated approaches.
• Leads test method execution and qualification efforts on their assigned products, identifying issues and driving resolution in collaboration with cross-functional teams.
• Contributes to risk management activities, supporting hazard identification, mitigation verification, and documentation in accordance with ISO 14971.
• Authors and maintains Computer Systems Validation (CSV) documentation per FDA guidance, including requirements specifications, validation plans, test scripts, and summary reports.
• Serves as a resource for junior engineers, providing informal mentorship and guidance on test development and best practices.
• Supports audit readiness by maintaining thorough and accurate documentation.
• Maintains regular and consistent attendance at the designated worksite and fulfills project responsibilities with limited supervision.

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.

• Working knowledge of FDA Quality System Regulations (21 CFR Part 820) & ISO 13485
• Familiarity with IEC 62304 and IEC 60601 requirements
• Familiarity with ISO 14971 requirements
• Experience with test case management software and ALM software (e.g. Polarion, Jira)
• Awareness of ANSI C63:27 requirements for wireless coexistence 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), probability and statistics preferred
• Experience supporting testing and validation of medical products through full life cycle including writing protocols, reports, and procedures
• Experience with project management and the ability to drive predictable outcomes from complex projects.
• Strong attention to detail, effective communication skills, and ability to work collaboratively in cross-functional teams

Education and Experience

Bachelor's degree in engineering or related field, with 2-8 years of medical device experience.

CERTIFICATES, LICENSES, REGISTRATIONS

ASQ CSQE or CQE preferred.

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).

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

Salary Range

Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $90,000 to $110,000 Full-Time Annual Salary