Subash Balasubramanin

MedTech NPD, Design Controls, Manufacturing, Quality and Process Validation leader with 18+ years of engineering experience, including 7+ years in regulated medical devices spanning orthopaedic implants, catheters, and UCC devices. Deep expertise in end-to-end New Product Development (NPD/NPI), Design Controls, Process Validation (IQ/OQ/PQ), SAT/FAT, Test Method Validation (TMV), Manufacturing Process Qualification, DHF/DMR/DHR, Risk Management (ISO 14971), DFMEA/PFMEA, and Supplier Quality. Proven track record supporting FDA 21 CFR Part 820, ISO 13485, EU MDR, and cGMP compliance through Design Verification & Validation, Design Transfer, and global manufacturing readiness.

Led EU MDR remediation, CAPA resolution, supplier quality programs, and cross-functional global NPI initiatives, consistently delivering compliant, robust manufacturing processes

MedTech NPI & Design Controls Lead - HCL Technologies - DePuy Synthes, Zuchwil, Switzerland

(2016-01 - 2023-10)

Clients: Becton Dickinson (BD), Johnson & Johnson (J&J) | Onsite: DePuy Synthes, Zuchwil, Switzerland

• Led orthopedic/knee implant NPD programs end-to-end — phase-gates, schedules, resources, V&V, RTM, Design Transfer, and ECO/ECR — in compliance with FDA 21 CFR Part 820 and ISO 13485.
• Executed IQ/OQ/PQ, TMV, FAI, and MSA/Gage R&R studies, reducing validation cycle time 20% and improving measurement reliability across NPI projects.
• Validated manufacturability of implant-specific processes — CNC, Swiss turning, EDM, grinding/polishing, surface finishing, and plasma spray/porous coating — ensuring performance and regulatory compliance.
• Qualified supplier processes for Ti/CoCr components (machining, finishing, coating, inspection), cutting rework 70% and improving NPI readiness 30%.
• Extended Design Controls and process validation expertise to catheter and UCC device programs, applying the same V&V and TMV rigor across product lines.
• Drove ISO 14971 risk management (DFMEA/PFMEA), CAPA/8D, and supplier audits, strengthening process control and supplier compliance; used MINITAB for process capability and TMV data analysis.
• Authored Master Validation Plans, TMV plans, WIs, SOPs, and OQ/PQ protocols/reports; developed incoming-inspection quality specs and maintained DMR.
• Managed CAD–PLM–manufacturing transfer (SolidWorks, Creo, Windchill), ensuring ECO/BOM accuracy, traceability, DHF/DMR readiness, and controlled release of design files and validation documents through formal change management (CR/CN).
• Led EU MDR/MDD gap assessments and cGMP remediation for Class III, IIb, and IIa devices across design, packaging, stability, sterilization, and lifetime-of-use requirements, aligned to GSPR; reviewed DHF documentation against FDA 510(k), ISO 13485, ISO 14971, and MDR.
• Partnered with Regulatory Affairs, R&D, Quality, PMCF, Clinical, and Marketing globally to update risk documentation (DFMEA/PFMEA), verification/validation records, inspection procedures, supplier quality documents, and standard test methods for EU MDR readiness; developed Master Validation Plans and end-to-end process flow charts covering critical raw materials, processes, CTQs, and suppliers.
• Managed the CAPA interface between suppliers and customers, driving root cause corrective actions on customer complaints; supported PMS/PSUR planning and QMS-based CAPA resolution to sustain ongoing regulatory compliance.

PPAP Specialist (Freelance) - GRG Poly Dynamics

• Review Level 3/5 PPAP submissions and PSW for plastic injection molded components, ensuring AIAG/APQP compliance (PFMEA, Control Plan, MSA, Dimensional Layout, Material/Performance results) supporting Tier-1 submissions to OEM customers.
• Direct supplier governance through VDA 6.3 audits, capability assessments, and risk-based evaluations, applying APQP/PPAP, SPC/MSA, FMEA, DFM/DFA, ECN/ECO, CAPA, and RCA/8D methodology to improve compliance and reduce scrap.

Design Review Leader - L&T Technology Services

(2024-12 - 2025-08)

Client: Vestas Wind Energy

• Led design reviews for wind turbine hub/nacelle/tower NPD programs; proposed an Agentic-AI supply chain optimization concept (TECHgium) projecting 20–25% handling-time reduction and ~15% forecasting improvement.

Engineering Services Team Lead - Axis Cades

(2024-05 - 2024-12)

Client: Caterpillar

• Led a cross-functional engineering services team on production-ready designs (manufacturability, GD&T, weld symbols, BOM); owned quality and delivery accountability.

Design/Drawing Review Lead - Geometric Limited

(2011-12 - 2016-08)

Client: Caterpillar

• Directed design/drawing reviews for NPI/CPI programs in Creo; recognized by Caterpillar's Managing Director (EDCI) for highest volume of continuous-improvement submissions company-wide.

Sr. CAD Engineer

(2005-01 - 2011-09)

• Delivered end-to-end mechanical design (concept through production drawings), GD&T, mechanism design, and PLM-based lifecycle management.

BSET - Mechanical - BITS, Pilani (2008)

PGDBA - Symbiosis University (2015)