20 Sep
|
Renechip
|
Hyderabad
20 Sep
Renechip
Hyderabad
Face-to-face interview date: Sunday, 20 September 2026, in Hyderabad. Please apply only if you are available to attend the in-person interview on this date; others are requested not to apply.
Location: Hyderabad
Employment Type: Full-Time
Work Mode: Work from Office
Experience : 4–14 Years
Notice Period: Immediate to 15 Days
Interview Date and time: Face to face,@20.09.2026,Hyderabad
Job Summary
We are looking for an experienced Systems Engineer / Lead Systems Engineer with strong expertise in product requirements, requirements traceability, verification documentation, risk management, and medical device design controls.
Key Responsibilities
- Review, analyze, and update product requirements to ensure completeness, consistency, and compliance with applicable quality 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 evidence.
- Manage requirements, traceability links, test records, risk artifacts, and engineering documentation using Codebeamer ALM.
- Review and align verification documentation, test evidence, and verification records with design control requirements.
- Support risk management activities, including FMEA, hazard analysis, risk-control linkages, and risk traceability matrices.
- Collaborate with SMEs, Quality Engineering, Regulatory Affairs, Product Development, Verification, and Systems Engineering teams.
- Support defect review, issue resolution, and documentation updates related to requirements remediation.
- Participate in design reviews and document review sessions to ensure consistency across requirements, verification, and risk management documentation.
- Perform impact assessments and support engineering change documentation when required.
Required Skills
- Strong experience in Systems Engineering and Requirements Management.
- Hands-on experience with Codebeamer ALM for requirements and traceability management.
- Good knowledge of requirements remediation and end-to-end traceability.
- Experience with verification documentation, test evidence, and design control processes.
- Knowledge of FMEA, hazard analysis, risk management, and risk-control traceability.
- Understanding of medical device standards and quality system requirements.
- Solid documentation, analytical, and cross-functional collaboration skills.
Qualification
B.E./B.Tech or Master’s Degree in Systems Engineering, Electronics, Electrical, Mechanical, Biomedical Engineering, or a related engineering discipline.
📌 Systems Engineer & Lead Systems Engineer (Hyderabad)
🏢 Renechip
📍 Hyderabad