Medical Device Validation Engineer II

Internetwork Expert; Carlsbad (CA); On-site; USD 90,000 - 110,000; Full time

Job summary

A medical technology company is seeking a Validation Engineer II to manage software verification activities for medical devices. This role involves collaboration with R&D and engineering teams to ensure compliance with FDA and ISO standards. Candidates should have 2-8 years of experience in V&V, a degree in biomedical engineering, and strong technical skills. Salary ranges from $90,000 to $110,000 annually, and the position is full time with no visa sponsorship offered.

Qualifications

• 2-8 years of experience in V&V or systems engineering for medical devices.
• Foundational understanding of FDA and ISO regulations.
• Exposure to supporting regulatory submissions like 510(k)s.

Responsibilities

• Leads verification and validation activities for assigned projects.
• Defines verification strategies for new product development.
• Creates and reviews design control documentation.
• Supports risk management activities.
• Collaborates with cross-functional teams.

Skills

FDA Quality System Regulations

IEC 62304 and IEC 60601 standards

defect tracking tools (e.g., Jira)

test method qualification methods

probability and statistics concepts

organizational and time-management skills

technical communication

detail-oriented

Education

Bachelor's or master's degree in biomedical engineering

Tools

Jira

Polarion

Job description

A medical technology company is seeking a Validation Engineer II to manage software verification activities for medical devices. This role involves collaboration with R&D and engineering teams to ensure compliance with FDA and ISO standards. Candidates should have 2-8 years of experience in V&V, a degree in biomedical engineering, and strong technical skills. Salary ranges from $90,000 to $110,000 annually, and the position is full time with no visa sponsorship offered.