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.
RequirementsThe 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.
- Foundational understanding of FDA Quality System Regulations (21 CFR Part 820) & ISO 13485
- Foundational understanding of IEC 62304 and IEC 60601 standards
- Foundational understanding of ISO 14971 risk management requirements
- Familiarity with defect tracking and test management tools (e.g., Jira, Polarion)
- Working knowledge of test method qualification methods (Gage R&R, Attribute Agreement Analysis) and competency using desktop lab equipment (function generators, oscilloscopes, etc.)
- Basic to working knowledge of probability and statistics concepts, and design of experiments (DoE)
- Experience supporting Design History File (DHF) documentation and Change Order routing
- Exposure to or experience supporting regulatory submissions such as 510(k)s
- Demonstrated organizational and time-management skills to support cross-functional project activities
- Ability to communicate technical concepts effectively with internal stakeholders and cross-functional team members
- Detail-oriented, deadline-driven, and able to work collaboratively in a team environment
Education and Experience- Bachelor's or master's degree in biomedical engineering or related field
- 2-8 years of experience in V&V or systems engineering for medical devices, or other regulated industries
CERTIFICATES, LICENSES, REGISTRATIONSASQ CSQE or CQE preferred.
Salary RangeAlphatec 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
Please Note: The employer will not sponsor applicants for work visas for this position.
