Vikrant Joshi Email & Phone Number

Saint Paul, Mn, Us

San Francisco, Ca, Us

Marlborough, Ma, Us

• Led the Global Design Assurance (DA) team including NPD DA, Systems Engineering, & Sustaining DA responsible for Systems Testing, Design Verification & Validation, Software Validation, Hazard Analysis, Design transfer, DHF review, component End-of-Life transition, NCs, CAPAs, HHAs, PSURs, & other post-market surveillance activities within Interventional Cardiology BU. Direct managerial responsibility for 3 Design Quality Supervisors, 11 Quality Engineers, & 4 design technicians.• Represented Design Assurance in Management Reviews, CAPA Review Board, Notified Body Audits, FDA inspections, & internal audits as an SME for Design Controls & Risk Management.

Dublin, Oh, Us

• Spearheaded the remediation effort for 17 Technical Files comprising of Class I, II, & III medical devices with the goal of achieving EU MDR compliance for Patient Recovery BU, while providing direction and leadership to multiple cross-site and cross-functional teams of subject matter experts. Direct managerial responsibility for 5 project managers with a total project cost of $200M. Responsible for overall project governance, compiling cross-site metric reports, maintaining project schedules, evaluating quality of deliverables, managing issue resolution, & providing monthly project status reports to Project Steering Committee.• Key member of the team responsible for creating a harmonized Corporate Quality Risk Management program including development of standardized risk tools such as DFMEA, Software FMEA, Risk Management Plan, Hazard Analysis, Task Analysis, Design Output Summary Report, Risk Mgmt. Report etc. & providing training & guidance to 5 design sites in accordance with 14971:2012.

Dublin, Oh, Us

• Led a team of 9 Design Quality Engineers & 2 Quality System Supervisors across 5 design sites responsible for creating a harmonized Corporate Quality Risk Management program including development of standardized risk tools such as DFMEA, UFMEA, PHA, FTA, RAC. Provided training on Measurement System Analysis (MSA). • Provided strong leadership for Quality System Simplification, & Process Deployment initiatives across multiple design sites with the goal of ensuring alignment with Corporate’s strategic priorities. Participated as a Quality Representative in Management Reviews, Leadership meetings, & Corrective Action Board meetings. Represented the Quality function in internal audits, TUV, FDA, & MDSAP audits. • Key member of a team that provided training on Design for Reliability & Manufacturability (DRM), Design of Experiments (DOE), Software Validation, & Configuration Management.

Minneapolis, Mn, Us

• Provided technical expertise to reliability engineering, product & process design teams for Class II and Class III medical devices, including ventilators, defibrillator electrodes, spinal cord stimulators, & vascular devices.• Supervised a team of 6 Sr. Design Quality Engineers responsible for conducting product risk assessment, Health Hazard Evaluations (HHA), & Field Corrective Actions (FCA).• Managed a global team of 5 supervisors & 14 Post-market Vigilance analysts responsible for accuracy, quality, & timeliness of complaint reporting, technical analysis & investigations. Led a six sigma (DMAIC) project to reduce complaint handling time by 56%, resulting in increased responsiveness & improved compliance. • Led a team responsible for conducting Process Quality Audits for Contract Manufacturers, conducted on-site supplier quality audits & oversaw implementation of Supplier Corrective Action Requests.

Minneapolis, Mn, Us

• Managed a team of 7 Design Quality Engineers responsible for leading pre-market & post-market risk management activities for Class II & III spinal implants. Key deliverables included completion of Risk Management (RM) activities per ISO 14971:2012 while leading a cross-functional team of Regulatory, Product Development, Design Quality, & Concurrent Engineers. Responsible for providing Quality Engg. support for design validation activities, design transfers & manufacturing transfers between multiple sites.• Provided expertise for improvement of Quality System, including quality planning, internal auditing/ inspection procedures, process control, quality records, corrective & preventive activities.

Minneapolis, Mn, Us

• Quality core team lead on 7 growth projects in Thoracolumbar therapy segment. Responsible for leading the Design Quality Assurance effort in development of the product from concept throughout the life of the product, supported ongoing compliance with the Quality System Regulations, 21 CFR Part 820, and ISO 13485/14971. • Spearheaded the Quality Engineering effort for implementation of ‘Unique Device Identification’ (UDI) program across all Spinal geographies. Managed conversion of 5 manufacturing sites to GS1/GTIN labeling standard with varying levels of complexity. • Key member of the team responsible for driving Quality System Simplification effort across all Business Units within the Medtronic’s Restorative Therapies Group.• Quality core team lead on ‘Advanced Medical Technologies (AMT)’ integration – a $35M European company acquired by Medtronic Spinal in 2012. Responsible for overall Quality Systems integration, including providing assistance to Spinal’s manufacturing sites, & AMT suppliers with the interpretation of quality requirements, first production run requirements, MSA, statistical sampling, & post-market risk management.

Minneapolis, Mn, Us

Ensured defendable engineering and scientific analyses are employed in the completion of design history files while complying with company policies and FDA regulations. Key deliverables included creating product performance analysis, risk analysis, failure mode effects analysis, design transfer to manufacturing, developing quality plans, inspection procedures & control plans for new product development and delivery.

• Assisted in developing a lean system using ‘5S’ and ‘Kaizen’ principles for manufacturing of seat inserts and achieved a 14% overall improvement in throughput of the assembly line. • Successfully completed a Process Improvement Project to reduce the defects in angle-plates manufactured on Pipe Bending machine using Six-Sigma principles and reduced scrap by 22%.

• Performed PFMEA and Process Capability studies with suppliers to reduce quality issues on sub-assemblies for valves, fuel injection pumps and dampers by 32%. Modified routings, & work standards, & created a value stream map to achieve synchronization of workflow. • Key member of a team that developed and applied Statistical Process Control & Capability Index procedures for the manufacturing of Transmission Casing for 55 hp tractors. Total estimated annual savings of US$829,000.

Executive Education, Artificial Intelligence In Healthcare

Master Of Business Administration - Mba

Master'S Degree, Industrial & Systems Engineering

Bachelor'S Degree, Mechanical Engineering

Professional Education, No Code Ai & Machine Learning