Job Overview:

- We are seeking an experienced System Engineer with a strong background in medical device product development, Design Controls, requirements traceability, and Design Verification & Validation (V&V;). The ideal candidate will have extensive experience working in regulated medical device environments and supporting the complete product development lifecycle.

- This role is responsible for ensuring end-to-end traceability from user needs through design inputs, risk controls, verification, validation, and product release while maintaining compliance with FDA regulations, ISO standards, and internal quality requirements. The successful candidate will collaborate closely with Engineering, Quality, Regulatory Affairs, and Product Development teams to support design control activities, remediation initiatives, and continuous quality improvements.

Key Responsibilities:

- Lead and support Design Controls activities for new and existing medical device products in compliance with FDA 21 CFR Part 820, ISO 13485, and applicable regulatory requirements.

- Establish, maintain, and review end-to-end traceability between user needs, design inputs, risk controls, verification activities, validation requirements, and product release documentation.

- Collaborate with cross-functional Engineering, Quality, Regulatory, Software, Hardware, and Product Development teams to ensure design requirements are accurately translated and verified.

- Develop, review, and maintain Design History Files (DHF), traceability matrices, design documentation, validation records, engineering reports, and technical deliverables.

- Coordinate and support Design Verification and Validation (V&V;) activities, ensuring products meet functional, performance, safety, and regulatory requirements.

- Prepare, review, and maintain engineering protocols, reports, technical documentation,



and design-control records throughout the product lifecycle.

- Monitor project progress by communicating timelines, project risks, compliance status, and technical updates to stakeholders and leadership.

- Identify opportunities to improve Design Controls, traceability processes, documentation quality, and systems engineering practices.

- Support design remediation, regulatory compliance, audit readiness, and quality improvement initiatives.

Required Qualifications:

- Bachelor's degree in Engineering or a related technical discipline.

- 10+ years of Systems Engineering experience within the medical device industry or another highly regulated environment.

- Robust expertise in Design Controls, requirements traceability, and Design Verification & Validation (V&V;).

- Demonstrated experience establishing traceability from user needs through design inputs, risk controls, verification, validation, and product release.

- Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and medical device quality system requirements.

- Experience working with cross-functional Engineering, Quality, Regulatory, and Product Development teams.

- Excellent technical documentation, written communication, and presentation skills.

- Solid analytical, organizational, and problem-solving abilities.

- Ability to manage multiple priorities in a fast-paced, highly regulated environment.

Preferred Qualifications:

- Experience with risk management processes in accordance with ISO 14971.

- Knowledge of risk analysis, hazard identification, risk assessment, and risk mitigation methodologies.

- Experience using requirements management and traceability tools.

- Strong understanding of Design Verification & Validation methodologies, protocols, and regulatory documentation practices.

- Experience supporting remediation programs, compliance initiatives, FDA inspections, or quality system improvements.

📌 System Engineer (Hyderabad)
🏢 Intellectt
📍 Hyderabad