HCLTech Mega WalkIn for Mechanical Design validation /DHF /MDR Engineer on 18th April in Chennai

HCLTech; Chennai; On-site; INR 600,000 - 900,000; Full time

Job summary

A leading technology company in Chennai is conducting a Mega WalkIn for the role of Mechanical Engineer, focusing on Design History Files and validation in the medical device industry. Candidates should have 3-10 years of experience and a Bachelor's degree in Mechanical or Biomedical fields. The role involves risk assessment, ensuring compliance, and collaborating with teams to update documentation. The walk-in will be held on 18th April at the company’s new cafeteria.

Qualifications

• 3-10 years of experience in validation within the medical device industry.
• Experience in DHF and MDR assessment and remediation.
• Strong understanding of medical device regulations including FDA 21 CFR Part 820.

Responsibilities

• Conduct risk assessments using methodologies like FMEA and ISO 14971.
• Collaborate with cross-functional teams to update legacy documentation.
• Ensure design control compliance throughout the remediation process.

Skills

Validation methodologies (IQ, OQ, PQ)

Risk assessment methodologies (FMEA)

Regulatory knowledge (FDA, ISO 13485)

Collaboration with cross-functional teams

DHF/MDR assessment and remediation

Education

Bachelor's degree in Mechanical/Biomedical, Quality Assurance, or Regulatory Affairs

Tools

QMS software and tools (TcU, SAP PLM)

Job description

HCLTech Mega WalkIn for Mechanical Engineer DHF ,Design Validation and MDR

DriveDate: 18th April Saturday (9AM-2PM)

Location: HCLTech Elcot Sez, New Cafeteria 2nd Floor, 602/3, 138, Medavakkam High Road

Position: Mechanical Engineer (Engineer, Lead Engineer, Technical Lead, Senior Technical Lead)

Experience: 3-10 years

Job Description

• Experience: 3-5 Years
• Bachelor's degree in Mechanical / Biomedical, Quality Assurance, Regulatory Affairs or a related field.
• Experience: 3-5+ years of 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.
• 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.
• 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.

Advanced Qualifications

• Bachelor's degree in Mechanical / Biomedical, Quality Assurance, Regulatory Affairs or a related field.
• Proven experience in medical device DHF / MDR assessment and remediation.
• In‑depth understanding of medical device regulations, including FDA 21 CFR Part 820.30 and ISO 13485:2016 requirements for design controls and DHF.
• Experience with risk management principles (e.g., ISO 14971) and their application to DHF.
• Experience with DHF remediation projects, especially for legacy products or in response to regulatory changes.
• Excellent communication, interpersonal, and collaboration skills for working with cross‑functional teams.
• Experience with QMS software and tools for DHF management (e.g., TcU, SAP PLM) is a plus.
• Good technical knowledge of projects executed with hands‑on experience (minimum 1 NPD and 1 ECM).
• Ability to manage multiple tasks and projects simultaneously.
• Good knowledge of RCA and CAPA.
• Good adaptability, problem‑solving and decision‑making skills.

Contact Person: Katherine Sylvia