Alphatec Spine is hiring a
Systems Engineer I

Summary

Join Alphatec Spine, Inc. as a Systems Engineer to contribute to product development, testing, and regulatory compliance.

Requirements

• BS Degree in Engineering
• Knowledge of testing and documentation of medical products
• Ability to handle multiple tasks while ensuring timely and accurate completion
• Proficient in developing test plans, protocols/test scripts, result reports
• Good understanding of requirements testing and traceability methodology within the product development life cycle
• Proven participation and leadership with cross-functional teams
• Bachelors Degree in and Engineering Discipline
• 0-2 years of experience of system engineering in the medical device industry

Responsibilities

• Perform system level testing
• Investigate issues found during development, testing, and/or from the field
• Collaborate with Hardware, Software and Mechanical Development, Marketing, Technical Services, and other project team members to ensure schedules and requirements are consistent with project expectations
• Create/assist other development groups (software, hardware, electronics) with requirements to align with system level requirements and to maintain consistent format
• Contribute to FDA 510(k) submission development or other regulatory filings as assigned
• Ensure compliance with FDA device regulatory requirements
• Train individuals involved in verification and validation activities as needed

Benefits

$82,000 to $95,000 Full-Time Annual Salary