Systems Engineer (Design Controls Remediation) - (Med Device)

Shoolin Inc is seeking a Systems Engineer to lead system-level design controls remediation activities for medical devices. This role focuses on ensuring complete traceability across design inputs, outputs, verification & validation (V&V), and risk management, while supporting system integration across hardware, software, and subsystems.

Responsibilities:

• Perform gap assessments of system requirements, architecture, and traceability against design controls
• Develop and remediate system-level specifications, interface documents, and risk analysis
• Support V&V planning and ensure complete traceability coverage
• Identify and resolve subsystem integration issues during remediation
• Collaborate with cross-functional teams to ensure design control compliance

Requirements:

• 5+ years of experience in systems engineering or biomedical engineering
• Strong experience with medical device design controls and traceability
• Hands-on experience with DHF remediation and gap assessments
• Strong knowledge of ISO 13485, 21 CFR 820, ISO 14971
• Experience with requirements management tools and traceability matrices
• Experience in risk management and system-level V&V planning for electro-mechanical or software-driven devices
• Strong documentation and analytical skills