Reshman A
Quality Engineer | Product Development | Design Control | ISO 13485 | ISO 14971 | Class III Medical Devices | MDR
- Role
- Lead Engineer at HCLTech
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Reshman A
Biomedical Engineering professional with 4.5+ years of experience in Class medical device product development, Design Quality, EU MDR 2017/745 compliance, and DHF remediation. Hands-on expertise in document and record control, Quality Management Systems (QMS), audit readiness, regulatory compliance, and risk management. Proven ability to manage controlled document lifecycles, ensure data integrity, track revisions, support internal/external audits, and drive continuous improvement initiatives. Strong understanding of FDA 21 CFR 820.30, ISO 13485, ISO 14971, and EU MDR requirements. Proven ability to collaborate with R&D, Quality, Regulatory Affairs, and Clinical teams to ensure products meet regulatory, quality, and customer expectations throughout the product lifecycle. Skilled in Windchill PLM for configuration and document management with strong technical documentation and audit readiness capabilities.
Experience
Lead Engineer
Oct 2025 — Present · Chennai, IN
Product Development | Design Quality | Document Control Specialist | ISO 13485 | Class Medical Devices | PLM (Windchill)
Education
Adhiyamaan College of Education, Hosur
Bachelor of Engineering - BE, Biomedical Engineering
2017 — 2021
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