Job Description
HCLTech is hiring for Mechanical Design EngineersExperience: Minimum of 6 months to Maximum of 2 yearsLocation: Chennai & MaduraiInterview Mode: Face to FaceQualification: 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...