Role and Responsibilities:

- Act as a Systems Engineering Lead, supporting day-to-day coordination with stakeholders, project teams, SMEs, Quality, Regulatory Affairs, R&D;, and leadership.
- Review assigned product documentation to confirm gaps, dependencies, acceptance criteria, and required remediation actions in collaboration with SMEs and leads.
- Drive remediation of requirements, design documentation, risk linkages, verification mappings, traceability records, and related systems engineering artifacts to support a complete and defensible corrected product baseline.
- Ensure product requirements are complete, consistent, testable, traceable, and aligned with applicable quality system expectations, regulatory requirements, and medical device standards.
- Establish, update, and verify traceability between requirements, failure modes, risk controls, test methods, verification activities, and objective evidence.
- Support alignment of FMEA and risk management documentation, ensuring appropriate linkage between hazards, harms, failure modes, mitigations, risk controls, and verification evidence.
- Review verification records and supporting evidence to ensure they adequately demonstrate requirement compliance and satisfy defined acceptance criteria.




- Populate and maintain corrected product data in Codebeamer to support the remediated Project baseline for requirements, traceability, lifecycle management, and closure readiness.
- Support regular project reviews, technical discussions, progress updates, issue resolution meetings, and escalation management.

Education & Experience:

- Bachelor’s or Master’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical discipline.
- 8+ years of relevant engineering experience, including significant experience in systems engineering and regulated product development.

Skills:

- Experience in medical device remediation, CAPA support, audit readiness, or regulatory remediation programs.
- Knowledge of medical device quality systems and applicable standards such as ISO 13485, ISO 14971, or similar regulated product standards.
- Experience working with global, cross-functional engineering teams.
- Familiarity with DHF, risk management files, verification records, defect records, and quality system procedures.
- Prior experience supporting customer, technical reviews, and steering committee updates.

📌 Systems Engineering Lead (Hyderabad)
🏢 Cyient
📍 Hyderabad