Michael Zalewski Email & Phone Number

California, 94086, Us

Abbott Park, Illinois, Us

Leads and directs business critical projects by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans. Examples include:- Successfully managed a site-wide critical project for EUMDR submission of our medical devices with a budget of over $1.3MM. Led a large cross functional team to track all deliverables and critical milestones for the project as well as presented status and risks to upper-level management on a regular basis. - Managed material obsolescence project by identifying new suppliers and executed testing for regulatory submissions to prevent stock out.- Managed a cleanroom (CER) expansion project to increase capacity of manufacturing by 35%. Required detailed planning and equipment ordering to ensure minimal disruption to commercial manufacturing.- Leads projects with varying degrees of scope and team members. Ranging from 5-25+ cross-functional core team members.- Estimate project levels of effort and resource requirements by using standard estimating techniques and tools, and work with stakeholders and core team to understand scope of effort.- Prepare project plans, schedules, and budgets by using project management tools such as Microsoft Project.- Resolves project issues by working with team members, project customers, and others as appropriate. - Team lead for Project Management team and SME for plan development, budgeting, scheduling, and quality.

Abbott Park, Illinois, Us

- Defined and led on-time completion of design control deliverables for Abbott’s MitraClip NTR/XTR and TriClip devices.- Provided subject matter expertise and ownership for risk management activities for MitraClip and TriClip devices for the design failure modes and effects analysis (DFMEA) and process failure modes and effects analysis (PFMEA). - Led a team of 4 for a critical complaint investigation CAPA project to identify the root cause of an emerging issue as well as implement corrective actions to resolve the issue.- Supported all activities as required to ensure successful transfer of design to manufacturing.- Developed design and inspection test methods for new products.- Provided guidance on defining the validation and verification strategy, including risk management mitigations, verification and validation plans, protocols, and reports.- Led the design verification and validation planning and execution for multiple new products which included active cross-functional root-cause analysis investigation and resolution activities.- Supported internal and external audit activities.- Mentored, developed, and led other team members. Managed summer intern.

Abbott Park, Illinois, Us

Responsibilities included manufacturing line support, process improvement, and investigations for non-conformances.- Led non-conformance, CAPA, and complaint investigations. Performed root cause analysis and corrective and preventative actions as required.- Maintained and diagnosed manufacturing issues for the commercial Clip subassembly and Clip Delivery System.- Tracked and trended yield in the manufacturing lines to ensure efficiency.- Led investigations to mitigate top hitting yield issues to meet financial targets.- Developed and implemented manufacturing tools and fixtures.- Direct support of the manufacturing line as the technical expert.- Generated and reviewed manufacturing change orders.- Participated in Kaizen and production improvement initiatives.Achievements- Took on a leadership role in a CAPA investigation and implementation which involved R&D FEA modeling, regulatory filing, supplier process changes, incoming inspection changes, and manufacturing process changes- Resulted in financial impact of +$1.1MM and over 4500 Clips at risk of being scrapped

Chicago, Il, Us

Responsibilities included logistical planning, managing, and maintaining replenishment for bottom-mount refrigeration nationwide across 11 distribution centers and over 750 stores.- Promoted within Inventory Supply Chain team to manage three times the inventory value ($650M), manage more complex products, and to play a significant role in vendor relations.- Analyzed data to provide weekly sales forecasts for all items based on promotional activity and sales history.- Partnered with the merchant team on pricing and successfully managed transition of new refrigeration lineup.- Closely monitored discontinued items to ensure sell through and reduce remaining inventory.- Trained and mentored new inventory analysts.

Chicago, Il, Us

Responsibilities included logistical planning, managing, and maintaining replenishment for top-mount refrigeration nationwide across 11 distribution centers and over 750 stores.- Managed the placement and replenishment of $190M of annual inventory to maintain an in-stock standard while achieving planned turnover and revenue growth.- Produced over $100K savings through reductions of unproductive inventory in stores and distribution centers.- Closely collaborated with vendors to ensure on-time shipments and troubleshoot product delays.- Optimized in-stock and reduced unproductive inventory.

Zurich, -, Ch

Responsibilities included participation in a lean manufacturing team to reduce waste on a production line.- Exceeded team goal to reduce average startup scrap by 50%.- Reduced changeover times and eliminated safety hazards by redesigning part of a production line to update it from an obsolete system.- Converted a slitting machine to run narrow cuts that helped improve efficiency. - AutoCAD 3-D modeling designer.

Bachelor Of Science (B.S.), Industrial Engineering

Education record