Medical Device Validation Engineer II (V&V)

ATEC Spine; Carlsbad (CA); On-site; USD 90,000 - 110,000; Full time

Job summary

ATEC Spine seeks a mid-level Validation Engineer II to lead software verification activities and collaborate across teams to improve validation processes. The ideal candidate will have experience validating medical devices, strong technical and communication skills, and a solid understanding of FDA standards.

This role involves creating test plans, ensuring compliance with ISO standards, and supporting cross-functional project activities with an annual salary range of $90,000 to $110,000.

Qualifications

• 2-8 years of experience in V&V or systems engineering for medical devices.
• Foundational understanding of FDA Quality System Regulations and ISO 13485.
• Familiarity with defect tracking and test management tools.

Responsibilities

• Leads verification and validation activities for assigned projects.
• Defines verification strategies for new product development.
• Supports risk management activities in accordance with ISO 14971.

Skills

Experience validating software-based medical devices

Technical skills

Troubleshooting abilities

Documentation skills

Communication skills

Cross-functional collaboration

Education

Bachelor's or master's degree in biomedical engineering or related field

Tools

Jira

Polarion

Job description

ATEC Spine seeks a mid-level Validation Engineer II to lead software verification activities and collaborate across teams to improve validation processes. The ideal candidate will have experience validating medical devices, strong technical and communication skills, and a solid understanding of FDA standards.

This role involves creating test plans, ensuring compliance with ISO standards, and supporting cross-functional project activities with an annual salary range of $90,000 to $110,000.