Validation Engineer, AIX

Validation Engineering for New Product Development & Sustaining Engineering with a focus on software systems. Under minimal supervision, the Validation Engineer will work closely with QE, R&D, Marketing, Product Development teams, Supply Chain, and Regulatory to bring products to market while ensuring compliance to applicable standards and regulations.

Essential Duties and Responsibilities

• Manage verification and validation activities for new product development & sustaining engineering projects.
• Provides Verification and Validation Engineering expertise for Design Controls to ensure efficient, effective, and compliant new product launches including requirements evaluation, end-to-end traceability and the establishment of V&V Plans.
• Manual and automated system test method development and qualification.
• Represent Quality Engineering when collaborating with designated personnel to develop various Computer Systems Validation (CSV) 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, Validation Summary Reports.
• Assist with Risk Management efforts in accordance with ISO 14971.
• Maintain 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.

• Understanding of the FDA Quality System Regulations (21 CFR Part 820) & (ISO 13485:2016)
• Understanding of IEC 62304, IEC 60601 requirements
• Understanding of ANSI C63:27 American National Standard for Evaluation of Wireless Coexistence requirements
• Understanding of ISO 14971 requirements.
• Experience with Test Case management software and ALM software (Helix) 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 biocompatibility requirements, SPC, DOE, 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 from four-year College or university in Engineering, or equivalent experience.
• 2-4 years of medical device experience.
• 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. $75,000 to $100,000 Full-Time Annual Salary Range