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.<...