Senior Systems Validation Engineer - Infusion Pumps

Swoon; Raleigh (NC); On-site; USD 96,604 - 137,587; Full time

Benefits offered by this job

Medical insurance

Vision insurance

Job summary

A leading healthcare technology company is seeking a Senior Systems Validation Engineer in Raleigh, NC. This role involves providing technical leadership and ensuring compliance with regulatory standards for medical devices. The ideal candidate has over 10 years of experience in software systems engineering and deep knowledge of IEC 62304 and ISO 13485. Responsibilities include mentoring teams, driving software development practices, and leading risk analysis initiatives. Competitive pay rate of $85.00/hr is offered for this 11-month contract position.

Qualifications

• 10+ years of experience in software systems engineering.
• Experience with electro‑mechanical or embedded medical devices.
• Knowledge of IEC 62304, ISO 13485, and risk management standards.

Responsibilities

• Serve as a technical leader, mentoring engineers.
• Drive software systems development best practices.
• Translate user needs into system and software requirements.
• Lead risk analysis and mitigation for software in regulated devices.
• Define verification strategies with full requirements traceability.
• Participate in software design reviews.
• Support Agile planning and execution.
• Partner with teams for effective design transfer.
• Ensure compliance with regulatory and quality system requirements.

Skills

Software systems engineering

Regulated industry standards knowledge

Strong communication skills

Documentation skills

Risk analysis

Education

Bachelor’s degree in Engineering or related field

Master’s degree preferred

Job description

A leading healthcare technology company is seeking a Senior Systems Validation Engineer in Raleigh, NC. This role involves providing technical leadership and ensuring compliance with regulatory standards for medical devices. The ideal candidate has over 10 years of experience in software systems engineering and deep knowledge of IEC 62304 and ISO 13485. Responsibilities include mentoring teams, driving software development practices, and leading risk analysis initiatives. Competitive pay rate of $85.00/hr is offered for this 11-month contract position.