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 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: Meticulous attention to detail for reviewing documentation and ensuring compliance.
• Teamwork and Collaboration: Proven ability to work effectively in a cross-functional team environment.
• Documentation Skills: Proficiency in creating and reviewing technical documentation, protocols, and reports.