Madhu Sindhe

Driving project management activities, employing relevant tools for the development of detailed timelines, and ensuring successful completion by resolving delays to maintain project trajectory. Developing critical metrics to monitor project performance and implement enhancements. Maintenance of financial oversight to limit budget variances.

1. Health, Safety, and Environment (CMR-ED and Environmental Regulation Assessment).

i. Ensuring that all products in the market conform with product safety and applicable environmental regulations, such as:

1. CMR-ED (Carcinogenic, Mutagenic, Repro-toxic, and Endocrine-disrupting substances per EU MDR sec. 10.4.1)

2. REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals)

3. RoHS (Restriction of Hazardous Substances)

4. California Prop 65
ii. Design for Compliance: Assessment of all the parts within the finished product to ensure they are compliant with the regulations and work with platform R&D to Design for Compliance

b. Lifecycle Management
i. Budget Management - Forecasting and tracking project expenditures to ensure alignment with financial forecasts, achieving minimal variance between projected and actual figures, ii. Financial Oversight - Managing direct project spends across multiple sustaining projects, maintaining strict adherence to budget constraints, iii. Reporting - preparation of detailed monthly financial reports and budget analyses, contributing to transparent and accountable financial management. Budget allocation - Responsible for issuing IO numbers for purchase order execution, considering the approved budgetary limits, c. Project Management of legacy product to meet MDR requirements
i. Project Management and Execution - Creation and execution of a comprehensive master schedule, ensuring timely delivery of MDR deliverables across various product portfolios to secure MDR Declaration of Conformity, ii. Meeting facilitation - Driving cross-functional meetings to monitor progress and guarantee adherence to product completion timelines, iii. Problem Resolution - Proactively addressing and resolving delays in deliverable completion, implementing solutions to maintain project trajectory, iv. Performance Metrics Analysis - Develop and evaluate quarterly and annual performance metrics, including KPIs, to assess outcomes and pinpoint areas for enhancement. Collaborative Management and reporting - Leading pivotal initiatives to achieve critical performance indicators by collaborating closely with Portfolio Heads, functional area leads, and internal/external stakeholders. Project Management supporting compliance to latest standards. Compliance Management - Meticulously lay out project timelines in MS Project, focusing on the compliance of products (surgical instruments) to new standards within set deadlines, while proactively resolving impediments to meet target dates.
ii. Project Plan visualization: Present project schedules and milestones with clarity, utilizing PowerPoint add-ons like ThinkCell and Office Timeline Pro to all stakeholders. iii. Meeting project Timelines: Lead weekly cross-functional meetings to drive task completion and maintain project momentum across all stakeholder group.

Leading the Cost Improvement projects by driving and assessing the Design controls and change requests with technical ownership of R&D deliverables. Working in tandem with Quality, Regulatory, Marketing, and other cross-functional teams to complete the design solutions over the continuum of the project.

•Creation/Revision of Component specifications. Packaging specifications, InspectionProcedure and routing of Change requests in EDMS
•Identifying the Design Verification Tests that must be performed in order to qualify thenew component by understanding the requirements from DIR, DHFR
•Performing Design Verification and related activities to analyze the impact ofcomponent change
•Updating impacted literatures such as Manufacturing procedure, Drawings, IFUs, specialinstructions sheet
•Determination of impact on Shelf life, Biocompatibility, Sterilization (SAL of 10-6), Humanfactors, Marketing Material Impact
•Drafting detailed Design Verification protocols, reports, Memo’s for qualifying the newdesign change. Involved in Design Trace matrix activities
•Active collaboration with Regulatory