Balkrishna (Bk) Shah Email & Phone Number

Saint Paul, Mn, Us

Maple Grove, Minnesota, United States

Mounds View, Minnesota, United States

Implemented continuous improvement tools to optimize workflows and manufacturing operations. Created and deployed a FTQ training structure at Medtronic Global sites in multiple global regions, as well as with key strategic contract manufacturing suppliers.• Reduced the number of non-conforming material reports (NCMRs) by 80% and decreased quality escapes by 90% by working with global senior site leaders and CMs to analyze monthly reports and address performance issues.• Achieved a 50% reduction in corrective actions and preventive actions (CAPA) by planning and executing projects to address 21 customer complaints from product hold orders (PHOs) and establishing standard processes to improve outgoing quality.• Maximized organizational capabilities by developing and certifying 300+ FTQ coaches across 35 sites, building an FTQ team with 6 team members, and implementing best practices for reducing customer complaints, quality escapes, FCAs, and PHOs.• Empowered 37 sites to self-sustain and deploy their own FTQ program by executing 60+ FTQ events, mentoring FTQ coaches, and introducing a “5 People” rule and “do it right the first time” concept to cultivate a zero-defect culture.• Led FTQ coaches to meet defect density map (DDM) and key process indicator goals by executing FTQ training strategies, gathering all sites’ quarterly quality output data, and leveraging key insights to continuously improve tactics.

Mounds View, Mn

Managed the cardiovascular group (CVG) and oversaw pre-market contract manufacturing quality initiatives (QIs) and FTQ programs for strategic planning. Planned, executed, and maintained internal and external programs with suppliers.• Enhanced FTQ program effectiveness by introducing new quality management processes, managing budget planning and execution, and providing quarterly performance reports to senior leadership to support long-term strategic planning.• Maintained high standards for outgoing quality and consistent cost savings by playing a key role in developing and integrating standard business practices, as well as innovative manufacturing policies and standard operating procedures (SOPs).• Enabled data-driven decision-making by monitoring and analyzing quarterly supplier quality scorecards and generating reports for senior management with key insights on quality escapes, FCAs, PHOs, and customer complaints.

Mounds View, Mn

Planned and executed initiatives to improve quality alerts and escape management and led projects to resolve customer complaints. Reviewed and implemented supplier changes through the process change notification (PCN) system, along with PCAD, IQ, OQ, PQ, PQRA, FAIR, and ECO documents and reports.• Improved profitability by leading multiple continuous improvement initiatives with Tier 1 and 2 suppliers and working closely with CMs and OEMs to resolve various technical and supply chain issues.• Leveraged in-depth subject matter expertise to manage performance qualifications, First Article Inspection (FAI) activities, and other processes required to create quality system reports that were provided to suppliers and used in quality system audits.

Eden Prairie, Mn

Oversaw global quarterly business reviews (QBRs), scorecards, and the field complaints matrix for strategic CMs. Managed various business agreements, including quality, supply chain, delivery, and development and post products.• Optimized QMSs by analyzing external audit results, identifying and communicating specific quality gaps, and directing a global team to execute new supplier development strategies, resulting in the completion of multiple audits with 0 findings.• Decreased backlog orders by 40% and NCMRs by 30% by developing and implementing new quality standards and requirements, as well as cultivating positive relationships with suppliers and communicating new quality expectations.

Global (Asia & North America)

•Lead the team to provide input from CM quality engineering documentation, Balance Score card matrix, processes and work instructions as an internal consultant. ($0.5M savings)•Lead and responsible for risk management processes to improve product performance.•Lead efforts to align corporate quality and process goals with different culture suppliers. •Involved in customer complaints, negotiation suppliers contracts, cost out strategy projects, and cost down projects to support profit plan for division. (over $1.6M savings)

Global

•Developed Design for Manufacturing standards for Printed Circuit Board assemblies for vendors and contractors. This effort reduced incoming material defects from 25% to 1%. •Established quality standards, DPMO, Six Sigma to meet total quality cost goals and Yield Improvement project to focus/troubleshoot on defects from inside and outside suppliers.•Increased productivity by 14% by developing the process/assembly flow for various new products.•Interfaced effectively and worked closely with all levels of management, other facility’s personnel and outside vendors to improve proto assembly from 80% to 94%.

Mn

• Developed process FMEA/DOE concepts to improve corrective actions for Disc Drive Assemblies. (Seagate Technology-customer) and Medical OEMs (Hearing Aid Assemblies).• Increased efficiency 8% by creating and analyzing FLOWCHART concepts for labor and equipment utilization in SMT and Bio-medical processes.• Strengthened engineering change order (ECOs) and Advanced Deviation authorization (ADAs) process to improve manufacturing and documentation/routers processes for ISO 9000.• Structured “World Class Manufacturing” (WCM) techniques for continuous improvement in Disc Drive (Seagate) medical and communication assembly applications.

Winona, Mn

• Performed technical design reviews and assured “error-proof” design for first proto builds for Chrysler 1996 minivan model.• Simplified necessary operating training with respect to machine operation and assembly techniques (lean) for process in high volume automotive assembly applications. Built 400,000 assemblies per year with less than 1000 PPM defects. • Increased productivity 8% by establishing corrective actions plans (8D and 5 W) on SMT Line.• Lead role with technicians, designers and other team members for process improvement projects.

India

• Verified elementary design work in submersible pump manufacturing, assisted with experiments and documentation for ISO 9000.• Investigated analyzed, researched new technologies and worked on process improvement projects.

Operations Quality Management, Continuous Improvement, Lean, Supplier Quality Management, 3.8

Masters, Manufacturing And Industrial Engineering Technology

Activities and Societies: President of Student Organization (ISO)

Bachelor Of Science, Mechanical Engineering