Maninder Sra

Background

About Maninder Sra

Full-Cycle Medical Device Leader (10+ Years): Strategic professional driving product success from Concept to Post-Market Service. Leveraged a unique blend of Product Management, QA/RA leadership, and hands-on technical service to ensure robust compliance (ISO 13485, FDA, EU MDR) and commercial viability. Global Regulatory & Quality Leadership 9+ years maintaining and ensuring compliance with ISO 13485, EU MDD/MDR, and FDA 21 CFR 820. Directly supervised a 9 member hardware design and testing team working under ISO 13485, FDA 820 QMS compliance. Product compliance incorporated guidelines from several standards - ISO, ASTM, IEC, BIS. Secured Clinical Trial Application (CTA) clearance for a Safety Syringe. Served as Process Owner for EU MDR CER and Labeling, assisting with full compliance files for Hernia Mesh and Skin Stapler. Technical Service & Operational Excellence Restored reliability for 500+ Class critical care devices (Defibrillators & Ventilators) over 3+ years of active technical service. Career-long application of Lean Six Sigma principles, my focus has been on driving quantifiable operational improvements. Success at utilizing DMAIC approach & six sigma lean tools in Toyota Production System environment - VOC, TGR TGW, VSM, 5 Why, DFMEA, Pareto, Kaizen, 5S, Process Control. Led a Lean Six Sigma project that significantly reduced project delays and improved handover completeness by streamlining NPD processes and enhancing communication. Implemented data-driven KPIs, proactive tracking tools, and clear accountability measures, including a SOP to bring clear process owner accountability. Significantly reduced delays per quarter for product launch. Product Portfolio Breadth Technical Versatility: Proven ability to rapidly assimilate & maintain complex technology across diverse clinical fields. Critical Care - Defibrillator, Ventilator. In-Surgery Products - Skin Stapler, Hernia Mesh, Laparoscopy Trocar, Novel Sternal Retractor Prototype, Safety Syringe. Biomaterial Implants Exposure to TKR, THA, Spinal fusion, dynamic stabilization techniques (Graf Ligamentoplasty), Stents, and Pacemakers. Orthotic Devices - Developed devices for complex articulation points: Spine, Knee, Ankle, Shoulder, Elbow, Hand, and Foot. Product & Market Strategy Drove market positioning by conducting primary client surveys, establishing market fit via sales feedback, and defining promotional pricing/branding for niche products. Forecasted seasonal demand based on disease burden to support production capacity.