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: Solid 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 verbal communication skills to effectively convey information to internal and external stakeholders, including auditors and regulatory agencies.
Analytical and Problem-Solving Skills: Strong analytical abilities to identify gaps, interpret data, and propose effective solutions.
Align risk assessment activities with global regulatory frameworks including FDA QSR, ISO 13485, EU MDR, and IEC standards
Conduct risk assessments using methodologies like FMEA, ISO 14971, and hazard analysis.
Develop and maintain Risk Management Files (RMF) in compliance with ISO 13485, ISO 14971, and FDA 21 CFR Part 820
Ensure design control compliance throughout the remediation process.
Collaborate with cross-functional teams to update legacy documentation and align with current regulatory standards.
Review and update D-FMEA and P-FMEA documents for accuracy and completeness
Participate in design reviews and lifecycle management to ensure risk controls are implemented effectively
Attention to Detail: Meticulou

📌 Mechanical Engineer (Madurai)
🏢 HCLTech
📍 Madurai