Mechanical Engineer

HCLTech is hiring for Mechanical Design Engineers

Experience: Minimum of 6 months to Maximum of 2 years
Location: Chennai & Madurai
Interview Mode: Face to Face
Qualification: Mechanical/Biomedical Engineering (2024/2025)

Job Description:
Qualifications/ JD:
Bachelor's degree in Mechanical / Biomedical , Quality Assurance, Regulatory Affairs, or a related field.
Experience: 1 to 1.5 years of experience in validation within the medical device industry, with a focus on IQ, OQ, and PQ activities.
Regulatory Knowledge: Strong understanding of medical device regulations, including FDA 21 CFR Part 820 and ISO 13485.
Proven experience in medical device DHF / MDR assessment and remediation.
Validation Expertise: In-depth knowledge of validation methodologies, including IQ, OQ, and PQ for equipment, utilities, and processes.
Risk Management: Familiarity with risk assessment methodologies (e.g., FMEA) and their application in validation activities....