Alphatec Spine
Validation Engineer II
Carlsbad, California, United States · Mid · Full-time
No sponsorship$90k-$110kDetected 43 days ago
StatisticsJiraSystems EngineeringMechanical DesignFDA RegulatoryMedical DevicesCommunication
About the role
- 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 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.
- Defines verification strategies for new product development, authoring high-quality test plans and protocols.
Responsibilities
- 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.
- 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.
- 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.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requirements
- The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Candidates must be authorized to work in the United States without the need for current or future employer sponsorship.
Compensation
- 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 Please Note: The employer will not sponsor applicants for work visas for this position.
Benefits
- Performs validation of non-medical-device software tools and supporting systems as required, ensuring appropriate rigor and documentation.
- Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.
Visa & Work Authorization
- At this time, ATEC Spine does not sponsor employment visas for this position
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This listing is sourced directly from Alphatec Spine's careers page and normalized into a canonical job model.