Madhu Sindhe

Lifecycle Management

• Managing project budgets exceeding (~ 600K) across multiple sustaining LCM projects in Waypoint (Planisware), performing monthly forecast-to-actual spend reconciliation with Finance teams and consistently maintaining less than 5-10% spend variance
• Ensuring strict financial discipline across concurrent projects by tracking direct spends, flagging deviations early, and aligning expenditures with approved budget constraints
• Preparing and analyzing detailed monthly financial reports, improving transparency, enabling data-driven decisions, and strengthening accountability across project stakeholders

Post Production & MDR Compliance Program Management

• Developed and Managing a centralized tracker to track and monitor 11+ regulatory Post-Production deliverables (PSUR, CER, PMCF Report/Plan, RMR, BRA, CEP, PMSP, SoTA/S&P LSRs, SSCP) across 80+ medical device products, consistently achieving >90% on-time delivery aligned with QMS & EU MDR requirements
• Leading recurring meetings with 10+ cross-functional stakeholders (R&D, QA, RA, Clinical, GMS) driving progress tracking, monitoring cascading documentations, and proactive identification and mitigation of compliance risks through structured agendas, detailed meeting minutes, and tracking action items
• Compiling quarterly performance metrics, delay dashboards, KPI trends and executive presentations, enabling senior leadership to make informed decisions and improvement oppurtunities
• Define, monitor and continuously refine team performance metrics, including KPIs and cycle times, to drive continuous improvement and operational excellence

Project Management - Safety & EMC Certification Activities

• Coordinating end to end product certification projects with TUV, Intertek, and Element for Safety/EMC evaluations covering standard updates, component changes & design modifications across surgical console platforms
• Built and maintaining detailed project timelines in MS Project, aligning project milestones and ensuring compliance of surgical instruments while mitigating potential delays.
• Presenting project schedules and milestones effectively using PowerPoint add-ons like ThinkCell and Office Timeline Pro.
• Leading weekly LCM Certification Project Schedule meetings with global participants, documenting detailed meeting minutes, action items, scope changes, and driving resolution of escalations across active projects to maintain project momentum

Health, Safety, and Environment (CMR-ED and Environmental Regulation Assessment) & Design for Compliance

• Ensured product compliance with safety and environmental regulations, including:CMR-ED (Carcinogenic, Mutagenic, Reprotoxic, and Endocrine-disrupting substances per EU MDR Sec. 10.4.1)
  REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals)
  RoHS (Restriction of Hazardous Substances)
  California Prop 65
• Assessed product components for regulatory compliance and collaborated with platform R&D teams to integrate compliance-focused design enhancements

• Led cost improvement projects (kitting, packaging, make-vs-buy) for high-volume disposable medical kits under a regulated design control framework (21 CFR 820, ISO 13485), driving cross-functional teams across R&D, Quality, Regulatory, Manufacturing, and Supply Chain
• Owned design verification deliverables: drafted and executed DV Protocols, Reports, and Technical Memos; maintained Design Traceability Matrices within the DHF for component changes (scalpel, dressing, syringe, PIVC replacements)
• Evaluated design change impact on shelf life, bio-compatibility, sterilization (SAL 10⁻⁶), human factors, and marketing materials; supported FAI, process validation (IQ/OQ/PQ), and supplier qualification activities
• Led packaging transition projects (Header Bag to Form-Fill-Seal, pallet to slip-sheet loading), supporting Ship Test activities, fit-check analysis, and process validation, generating significant cost savings
• Managed Design Change Control documents and Change Requests through EDMS; executed BOM updates in ERP for all affected kits post-design approval
• Collaborated actively with Regulatory Affairs to assess re-registration and regional regulatory impact resulting from design changes; drove cross-functional meetings to ensure timely project completion