Padi Parthi

Results-driven Lead Engineer with 9+ years of experience in medical device product development, quality assurance, and regulatory affairs. Proven expertise in EU MDR 2017/745 remediation for Class IIb & III devices, Design History File (DHF) management, and technical documentation for regulatory submissions. Hands-on experience with ISO 13485, ISO 14971, IEC 60601, IEC 62304, & IEC 62366-1.

Skilled in cross-functional collaboration, risk management (DFMEA/MDHA), and Agile PLM. Strong track record of achieving 100% regulatory compliance for complex surgical devices.

Lead Engineer – Medical Device Product development, Quality & Regulatory - HCL Tech Limited - Chennai

(2021-03)

• Led EU MDR 2017/745 remediation for Class IIb & III neurosurgical devices, achieving 100% compliance with EU MDR requirements and ensuring uninterrupted market authorization.
• Conducted comprehensive gap assessments and executed remediation plans against EU MDR 2017/745, MDD 93/42/EEC, and applicable harmonized standards, managing end-to-end transition planning.
• Remediated Design History Files (DHF) using a Requirement Traceability Matrix (RTM) approach — mapping design inputs through design validation — ensuring complete audit-ready technical documentation.
• Developed and reviewed Design Verification Plans, Sample Build Protocols, Conditioning Protocols/Reports, Biological Safety Evaluation Plans, and Design Verification Reports per applicable standards.
• Prepared and compiled technical documentation for regulatory submissions to Notified Bodies; verified product compliance via General Safety and Performance Requirements (GSPR) checklists.
• Supported remediation activities for electrical safety (IEC 60601) and software lifecycle (IEC 62304) standards, collaborating with cross-functional engineering and software teams.
• Developed comprehensive Usability Engineering documentation including Use Specifications and User Specifications in alignment with IEC 62366-1.
• Participated in risk management activities including DFMEA and Medical Device Hazard Analysis (MDHA), identifying and mitigating design and process risks per ISO 14971.
• Executed delta gap and impact assessments to evaluate effects of updated regulatory and technical standards on existing product documentation.
• Performed gap assessments for product labelling and Instructions for Use (IFU) per ISO 15223 and applicable MDR Annex requirements.
• Supported ISO 13485 audit readiness, maintained quality system documentation, and contributed to complaints handling processes (PMS/Post-Market Surveillance).
• Managed product data, documentation, and change control processes using Agile PLM; collaborated cross-functionally to define system and interface requirements for safety-critical devices.

Quality Engineer - MVM Perfect Tool Makers Pvt. Ltd. - Chennai

(2016-09 - 2020-09)

• Performed incoming inspection, in-process inspection, and final inspection of purchased parts, subassemblies, and finished goods against engineering drawings using micrometers, calipers, bore dial gauges, and 2D height gauges.
• Prepared PPAP documentation packages including Process Flow Diagrams, Control Plans, and PFMEAs; generated 8D reports to drive root cause analysis and corrective actions for non-conformances.
• Maintained calibration schedules, MMR plans, and instrument history cards; reduced instrument service costs through proactive calibration program management.
• Led supplier audits and contributed to supplier selection and development activities, resulting in measurable reduction of incoming non-conforming parts.
• Drove continuous improvement initiatives including Kaizen and Poka-Yoke error-proofing; implemented inspection templates that reduced overall inspection cycle time.
• Handled customer complaints, performed root cause investigations, and contributed to corrective action initiatives leading to improved customer satisfaction scores.

B.E. - Mechanical Engineering - Saveetha Engineering College, Anna University (2012 - 2016)

Internship - CNC Machining, Honing, Broaching, Surface Grinding, Hobbing - Fine Components (2016 - 2016)