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.
