Senior Remediation Engineer

Job Title: Systems Engineer (Medical Device)

Job Summary: The Systems Engineer will act as the technical lead for system-level integration and traceability activities during Design History File (DHF) gap assessments. The role ensures that Design Inputs, Design Outputs, Verification & Validation (V&V), and Risk Management are complete, aligned, and fully traceable across hardware, software, and subsystem components of the medical device.

Key Responsibilities:

• Perform detailed gap assessments of system requirements, architecture, and traceability matrices against Design Inputs, Design Outputs, and V&V documentation.
• Develop and/or remediate system-level specifications, interface control documents, and risk analysis artifacts.
• Support the creation and maintenance of V&V master plans to ensure complete system-level verification and validation coverage.
• Identify, analyze, and resolve integration issues across hardware, software, and subsystem interfaces during remediation efforts.
• Ensure end-to-end traceability across requirements, risk controls, and test artifacts.
• Collaborate with cross-functional teams including hardware, software, clinical, quality, and manufacturing to maintain design control compliance and consistency.

Required Qualifications:

• Bachelor's degree in Systems Engineering, Biomedical Engineering, or a related technical field.
• Proven experience in medical device development, including design controls and traceability.
• Strong knowledge of regulatory standards such as ISO 13485, 21 CFR Part 820, and ISO 14971.
• Experience with requirements management tools and traceability systems.
• Background in risk management and V&V planning for complex electro-mechanical and/or software-driven devices.
• Strong analytical, problem-solving, and technical documentation skills.

Preferred Qualifications:

• Prior experience with DHF remediation or gap assessment projects.
• Experience working in cross-functional, regulated environments.
• Familiarity with system integration in complex product architectures.

Key Skills:

• Systems integration and architecture
• Requirements traceability
• Risk management (ISO 14971)
• Verification & Validation (V&V) planning
• Regulatory compliance (ISO 13485, FDA 21 CFR 820)
• Cross-functional collaboration

Work Environment:

• Regulated medical device development environment
• Collaboration with multidisciplinary engineering and quality teams