HCLTech Mega WalkIn for Mechanical Engineer DHF ,Design Validation and MDR on 18th April in Chennai
Join a team that values innovation, growth, and impactful work. Don't miss the chance to work with cutting-edge Project in SME and be a part of something transformative!
Apply:https://forms.office.com/r/H5amSL16mY
DriveDate:18th April Saturday (9AM-2PM)
ContactPerson: KatherineSylvia
VenueLocation: Chennai
HCLTech Elcot Sez,
New Cafeteria 2nd Floor
602/3, 138, Medavakkam High Road,
Sholinganallur, Chennai-600119
Position:Mechanical Engineer (Engineer,Lead Engineer, Technical Lead,Senior Technical Lead)
Experience: 3-10 years
Job Location: Chennai
Skill:
Mechanical Engineer with Change control Experience , SAP/PLM, DHF,Design Verification and validation,Medical Device,Design Control,Design change controls, Design reviews and Design transfer.
JD:Experience: 3-5 Years
- Bachelor's degree in Mechanical / Biomedical, Quality Assurance, Regulatory Affairs, or a related field.
- Experience: 3-5+ 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.
- 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
JD:Experience: 5-10 Years
- 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 and/or in response to regulatory changes.
- Excellent communication, interpersonal, and collaboration skills for working with cross-functional teams.
- Experience with Quality Management Systems (QMS) software and tools for DHF management (e.g., TcU, SAP PLM) is a plus.
- Good Technical knowledge of the projects executed with hands-on experience (Minimum 1 NPD and 1 ECM project experience).
- Ability to manage multiple tasks and projects simultaneously.
- Good knowledge of RCA and CAPA.
- Good adaptability problem solving and decision-making skills.
ContactPerson: KatherineSylvia
Interested candidates can share their CV on below mail id [Confidential Information] with Below details Current Company, Current CTC, Expected CTC, Notice Period, Location.
