Validation Engineer III
Alphatec SpineCarlsbad, California, United States
Posted September 9, 2025
107000 - 117000 USD full time
Full Time
About the Company
ATEC is a medical device company dedicated to revolutionizing the approach to spine surgery through innovation. ATEC’s Organic Innovation Machine™ is the greatest concentration of spine knowhow in the industry and committed to the creation of clinical distinction. Leveraging 100% spine focus and expertise, we seek to improve spine surgery by rethinking, redesigning and seamlessly integrating the technologies required from the ground up. The innovation that results from that process is being rapidly adopted because, like us, spine surgeons covet informatic and procedural sophistication that enables more predictable, more reproducible care. Our flagship technology, the Prone TransPsoas (PTP™) Procedure, leveraged decades of experience to advance first-generation lateral surgery with a more familiar patient position and elevated neuromonitoring. EOS imaging, the backbone of ATEC’s informatic ecosystem, provides radiographic imaging, enabling standing, full-body, global alignment assessments. We are further developing EOS technology to elevate spine care with unprecedented capabilities. Our vision is to be the standard bearer in spine. Visit our website for more information: www.atecspine.com
Job Description
Alphatec Spine is seeking a Validation Engineer III to lead design verification and validation projects for new product development and sustaining engineering. The role involves working closely with Quality Engineering, R&D, Marketing, and Regulatory to bring products to market, ensuring compliance to standards and regulations. This is a minimally supervised role with strong leadership responsibility.
Requirements
- Proficient in FDA Quality System Regulations (21 CFR Part 820) & (ISO 13485:2016)
- Proficient in IEC 62304, IEC 60601 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
- 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
- Demonstrates comprehensive knowledge of project management techniques to ensure predictability of complex projects
- Must be deadline-oriented and detail-oriented, an effective communicator, and able to work within a team environment
- Bachelor’s degree in engineering or related field, with a minimum of six (6) years of medical device experience
Benefits
- Competitive Salary
- Equal Employment Opportunity
