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. Communication Skills: Excellent written and ver...