Systems Engineer

Role and Responsibilities:

1.    Review, analyze, and update product requirements to ensure completeness, consistency, and compliance with applicable quality system requirements and medical device standards.

2.    Perform requirements remediation and establish end-to-end traceability between user needs, system requirements, design inputs, risk controls, verification activities, and verification evidence.

3.    Utilize Codebeamer ALM to manage requirements, traceability links, test records, risk artifacts, and engineering documentation.

4.    Review and align verification documentation, test evidence, and verification records to ensure compliance with design control expectations.

5.    Support risk management activities by reviewing and updating FMEA documentation, hazard analyses, risk-control linkages, and risk traceability matrices.

6.    Collaborate closely with SMEs, Quality Engineering, Regulatory Affairs, Product Development, Verification, and Systems Engineering teams.

7.    Support defect review, issue resolution, and documentation updates associated with remediation.

8.    Participate in design reviews and document review sessions to ensure consistency across requirements, verification, and risk management artifacts.

9.    Perform impact assessments and support engineering change documentation where applicable.

Education & Experience:

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

2.    Minimum 3+ years of working experience in Systems Engineering.

3.    Experience supporting medical devices with electromechanical systems consisting of mechanical, electrical, electronic, firmware, and software components.

4.    Proven experience working with Design Control documentation and regulated product development.

5.    Hands-on experience using Codebeamer for requirements management, traceability management, test management, and document control.

Skills:

1.    Experience in requirements analysis, decomposition, traceability management, system integration, verification & validation (V&V), and design control processes.

2.    Hands-on proficiency with Codebeamer ALM for requirements management, end-to-end traceability, risk linkage, and remediation of engineering documentation.

3.    Medical Device Regulatory and Quality knowledge, including FDA Design Controls, ISO 13485, ISO 14971, DHF, FMEA, risk management, and requirements-to-verification traceability.

4.    Technical documentation and remediation skills, including review and correction of requirements, verification evidence, risk management artifacts, test records, engineering documents, and product data migration.

5.    Strong 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