Role and Responsibilities:

- Review, analyze, and update product requirements to ensure completeness, consistency, and compliance with applicable quality system requirements and medical device standards.
- Perform requirements remediation and establish end-to-end traceability between user needs, system requirements, design inputs, risk controls, verification activities, and verification evidence.
- Utilize Codebeamer ALM to manage requirements, traceability links, test records, risk artifacts, and engineering documentation.
- Review and align verification documentation, test evidence, and verification records to ensure compliance with design control expectations.
- Support risk management activities by reviewing and updating FMEA documentation, hazard analyses, risk-control linkages, and risk traceability matrices.
- Collaborate closely with SMEs, Quality Engineering, Regulatory Affairs, Product Development, Verification, and Systems Engineering teams.
- Support defect review, issue resolution, and documentation updates associated with remediation.
- Participate in design reviews and document review sessions to ensure consistency across requirements, verification, and risk management artifacts.
- Perform impact assessments and support engineering change documentation where applicable.

Education & Experience:

- Bachelor's or Master's degree in Systems Engineering, Biomedical, Mechanical, Electrical, Electronics, Mechatronics, or a related engineering discipline.




- Minimum 3+ years of working experience in Systems Engineering.
- Experience supporting medical devices with electromechanical systems consisting of mechanical, electrical, electronic, firmware, and software components.
- Proven experience working with Design Control documentation and regulated product development.
- Hands-on experience using Codebeamer for requirements management, traceability management, test management, and document control.

Skills:

- Experience in requirements analysis, decomposition, traceability management, system integration, verification & validation (V&V;), and design control processes.
- Hands-on proficiency with Codebeamer ALM for requirements management, end-to-end traceability, risk linkage, and remediation of engineering documentation.
- Medical Device Regulatory and Quality knowledge, including FDA Design Controls, ISO 13485, ISO 14971, DHF, FMEA, risk management, and requirements-to-verification traceability.
- Technical documentation and remediation skills, including review and correction of requirements, verification evidence, risk management artifacts, test records, engineering documents, and product data migration.
- Robust analytical, communication, and collaboration skills, with the ability to work effectively with cross-functional teams, SMEs, Quality, Regulatory Affairs, and Engineering stakeholders.

Primary Location:

Hyderabad, Telangana, India

📌 Systems Engineer (Hyderabad)
🏢 Cyient
📍 Hyderabad