Sustaining Engineer I — Medical Devices & Validation

OriGen Biomedical

Austin (TX)

On-site

USD 75,000 - 95,000

Full time

14 days+

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Job summary

OriGen Biomedical, Inc. is seeking a Sustaining Engineer I to support on-market Class I/II devices with technical support and training. You will assist manufacturing and development engineers, improve processes, plan validations, and implement cost-saving initiatives.

The role emphasizes risk assessment, documentation, and cross-functional teamwork to ensure device reliability and regulatory compliance. This position involves hands-on support in a regulated environment and may require

Qualifications

Knowledge of FDA regulations and GMP guidelines for medical device validation.
Proven skills in coordinating and managing day-to-day tasks and meeting deadlines.
Proficiency in technical and layman writing.

Responsibilities

Draft and execute test protocols to demonstrate product capabilities.
Manage design history files for on-market devices and maintain standards.
Collaborate with marketing and regulatory to identify new markets and plan validation activities.
Assess risk to design, manufacturing, and use of on-market devices.
Perform root cause analysis of product-related problems and drive corrective actions.
Create supply-chain contingency plans for critical raw materials.