Jonathan Kalinowski Email & Phone Number

Saint Paul, Mn, Us

Arden Hills, Minnesota, Us

Arden Hills, Minnesota, Us

Perform OpEx and Manufacturing Engineering activities to support rapid growth of the BioPharma products. Support multiple manufacturing sites (Roseville and NorthPark), including night and weekend shifts. Partner with Production Team and CI Director to successfully develop and implement production floor layouts for both NorthPark and Roseville sites. Facilitate utility placement, coordinating with Facilities Manager, Outside Contractors, and Production Leadership. Facilitate and Partner with Process Techs to plan and carry out equipment moves and execute equipment verifications. Provide Design Input for Roseville Cleanroom Expansion. Lead and Facilitate implementation of ‘metered flow’, concepting 5x5 Trays and Storage Tower with Water Spider material distribution. Provide Leadership of Process Techs with daily work direction and project work. Develop and Implement ‘Scrap Codes’ in Oracle with help from Mfg Managers to provide meaningful information on scrap transactions. Design, Develop, and Implement production processes and supporting equipment including Helium Tank Empty Alarm, Helium Dispense Modules, Pressure Decay Testing, Burst Test Sampling Scheme, One-piece flow (multiple product lines), and Air Wash Station. Perform A3 Problem Solving and utilize Lean Principles (Waste Elimination, Line Balancing) to address major product and process performance issues resulting in 30% Scrap Reduction, 80% WIP Reduction, and other measurable improvements. Perform Critical Capacity Improvements for multiple Product Lines resulting in +55% Throughput (AQG Sani), +100% Throughput (STC2), +160% Throughput (AQX/AQL). Support multiple Automation CapEx projects providing input and requirements for SOW and URS. Perform Time Studies for Labor Calculations and update Oracle Routers. Customer and Audit facing representative for CPC Manufacturing. SME for high tech manufacturing processes including Helium Leak Test, Pressure Decay, Heat Staking, Plastic Welding.

Oakdale, Minnesota, Us

Promoted to Quality Manager. Responsible for identifying and prioritizing opportunities to improve quality, reduce waste, and lower costs. Successfully reduced scrap rate by 55% through leadership of defect reduction initiative and utilizing Lean Principles. Established and Lead weekly Process Improvement teams, focusing on moving identification of scrap and waste upstream into each Unit Op as opposed to identifying it at Final Inspection. Establish and present Defect Reporting to executive management, and utilize report data to determine focus of process improvements. Instill value of using process improvements to achieve quality throughout the company. Developed Test Result Reporting database system to establish real time data reporting, SPC, and decreased incident reaction time. Actively serve on the Employee Engagement Team to re-enforce company Core Values through events and incentive programs.

Oakdale, Minnesota, Us

Responsible for ensuring production is carried out in an efficient manner while guaranteeing consistency and quality. Transform the company culture to embrace quality and build quality into product designs and manufacturing processes. Design and implement Sampling and Inspection systems throughout production including Incoming, In-process, and Final Inspection. Establish Document Control System, and establish documentation of Production Processes to provide basis for Standard Work and employee training. Lead/coordinate Workflow and equipment updates of Assembly Workcell resulting with increased output and efficiency. Perform DOE's to optimize quality and cycle time of Foam Saw. Perform Capability Studies of Core Cut & Place machine, and update operating parameters based on study results to improve performance and quality. Attend Certified SolidWorks training to gain knowledge of CAD design techniques. Perform CAD design of simple fixtures and components for equipment upgrades, and source machine shops to carry out machining. Assist R&D with Process Development for new products, and provide statistical analysis to validate process performance. Assist with installation of Laser Cutter, and generate cutting patterns. Assist with development of Vision System to detect improper glue application by generating reference images and detection limits and establishing communication with PLC and automation components. Perform 8D Problem Solving technique to successfully eliminate major Customer product issue. Establish and present Defect Reporting to executive management, and utilize report data to determine focus of process improvements. Provide daily production support to troubleshoot and correct equipment issues.

Deerfield, Illinois, Us

Took opportunity to further gain experience in Manufacturing and Quality of Medical Devices. Improved Yield of Vascular Products from 45 to 82%. Continuation of leadership development by successfully leading cross-functional teams on improvement initiatives. Successfully lead Value Stream Mapping, Kaizen, Test Method Validation, Manufacturing and Test Equipment Validations, Supplier Injection Mold Improvements and Mold upgrades. Managed direct report to successfully complete Ergonomic re-design for Shunt Assy Fixture. Performed Design Integration and Quality System Integration activities for acquisition of External Tissue Expander product. Manage and perform re-validation of Tyvek sterile barrier packaging system for multiple products. Wrote and executed protocols and reports for packaging validations, equipment qualifications, and engineering investigation studies, in accordance with FDA and ISO regulations. Performed NCR, CAPA, Complaint Reporting, FMEA, PFMEA, and Document Changes.

Ball Ground, Georgia, Us

Promoted to Product Engineer from previous Quality Engineer position. Served as Lead Engineer for Product Improvement / Product Development and Process Improvement. Responsible for Hiring, Development, and Performance Management of 3 direct reports and 1 indirect report. Project Lead for multiple projects including SCADA system upgrade, Wrapping Machine upgrade, Roto-molding re-tool, Label stock sourcing and Qualification, and Vapor Shipper design improvement. Supplier Development experience for new injection molded component, and new metal stamped component. Business Process Owner of Engineering Design Change and NPD process for New Prague Site.

Ball Ground, Georgia, Us

Moved to BioMedical Division into a Quality/Manufacturing role. Leader of Equipment Validation/Qualification, Process Improvement, and CAPA. Further developed leadership and engineering skills through leadership and execution of projects including Optimization, Throughput Improvement, Defect Reduction, Standardization and Capacity Expansion, Welding, and Automation. Established and monitored key process and product performance metrics to present at Management Review and Monthly Ops meetings. Made significant contributions to product and process designs resulting in downward trending Complaint PPM. Served as supporting engineer for Product Development projects. Further developed skills in Quality Systems by implementing standalone quality system for compliance to parent quality system and ISO 13485.

Ball Ground, Georgia, Us

Reviewed, established, and communicated project requirements and technical specifications for highly engineered cryogenic liquid / gas distribution and storage systems to ensure product compliance and performance. Gained knowledge of the industry through development and implementation of internal specifications, SOPs, and documentation for compliance to various industry standards including ASME Section VIII, CFR Title 49, CGA, PED, NFPA, ASTM, ISO 9001. Replaced outdated paper processing system by implementing a streamlined electronic Non-conformance System, improving timeliness, handling, and communication. Responsible for owning / initiating, investigating, and completing NCR and CAPA events. Gained experience with Quality Systems by establishing a Product/Process Audit system and by serving as Lead Auditor for Internal Quality System Audits. Developed Supplier Relationships through performing Supplier and Component Qualifications.