Teams at DEKA Research & Development

The Senior Test Engineer will develop test plans, perform reliability assessments, and contribute to regulatory submissions within medical device R&D.

Review and evaluate medical device complaints, determine reportability, document investigations per FDA/QMS requirements, support CAPA and audits, interface with manufacturers and regulatory bodies, generate improvement reports, and develop training. Serve as subject matter expert for complaint handling and collaborate cross-functionally to close investigations and maintain compliant complaint processes.

The Process Controls Engineer designs and integrates clean environment subsystems within regulated devices, ensuring environmental performance, contamination control, and compliance throughout the device development lifecycle.