Michael Clark, M.Eng. Email & Phone Number

Charlotte, North Carolina, Us

Kansas City, Mo, Us

Ensure quality and regulatory compliance of UltraSource LLC while leading a team of four direct reports• Manufacturing lead for ERP migration efforts to Microsoft Dynamics 365, Finance and Operationso Project manager for integration effort with launch of the 3DExperience platform• Implementing Quality Management System (QMS) from the ground upo Data visual creation through Microsoft PowerBI platformo Data collection via Sharepoint Lists and integration with Microsoft Teamso Key processes implemented include Nonconforming Material, Material Review Board, Engineering Change Process, Engineering Change Board• Steering committee leader for implementation of Quick Response Manufacturing (QRM)• Responsible for regulatory submissions/maintenance with Intertek for Electrical Testing Laboratories (ETL) markings• Led implementation and installation of two automated materials management machines (large capital expense, Vertical Lift Machines from Modula)o Significant reduction in inventory footprinto Processes implemented for material picking, visual management of totes, and warehouse flow of machineso Integrating into Dynamics 365 ERP system• Lead Manufacturing Engineering group responsible for 3D Printing, Laser Engraving, and Vinyl Cutting work cellso Grew 3D printing capabilities and technology (details proprietary)o Transitioned out of date schedule to more accurate PowerBI schedule for increase in on-time delivery (OTD) of 3D printed partso Expanded collaboration with Marketing and other departments for use of laser engraver and vinyl cutter• Enhancing safety culture as member of safety committee and manufacturing lead for safety activities• Transforming outdated buildings and infrastructure as manager of all Facilities responsibilitieso Removal of processes posing safety hazardso Transplanting work cells within the campus to enlarge inventory warehouse footprint

Riverside, Mo, Us

Ensured quality and regulatory compliance of Marlen’s diverse portfolio of industrial food processing systems.• Managed documentation and processing of nonconforming goods through Syteline v8.o Implemented KPIs for 24 hour response time from suppliers for nonconformances. • Refined and managed the receiving inspection process along with being responsible for measurement of incoming goods. o Targeted a 33% or greater reduction of receiving inspection in 2021. Will be achieved by releasing a receiving inspection process that uses nonconformance and customer complaint data to decide which suppliers require inspection. o Responsibility for evidence of conformance was pushed to the supply base where financially feasible. • Developed current supply base through exposure to root cause analysis techniques and completion of corrective action reports. Nonconformance and complaint data was used to prioritize suppliers. • Implemented Request for Information procedure for smaller corrective actions. o Planned to implement KPI of < 30 days for corrective action closure (minus verification of effectiveness). • Facilitated all aspects of Supply Chain department by performing tasks such as following up on expedited material and meeting suppliers to discuss volume buy partnerships.

Landskrona, Se

Liaison for all supplier quality and sourcing activities for four NPD projects (budgeted approx. $2mil USD)• Manage reporting and execution of sourcing project toll gate deliverables for engineering, quality, regulatory compliance, and operations departments.• Develop and onboard new suppliers while continuously improving or phasing out others based on sourcing strategy.• Cultivate relationships with overseas suppliers (China, India, Turkey, Europe) for Advanced Product Quality Planning (APQP) activities including tooling design, construction, and part validation o NPD for 6M USD per year sales project on a 0.6M capital investment for 22 tools (28 different part numbers). o 1.4M USD per year savings on a 0.5M capital investment for 29 tools (41 different part numbers). o 1.8M Euro per year savings on a 0.3M Euro capital investment for 12 different tools for Hungary facility.• Collect and manage supplier compliance criteria for Conflict Minerals, IATF 16949 and ISO 14001 compliance, and corporate social responsibility utilizing the Market Dojo and NQC online platforms• Outline and complete AIAG compliant supplier part qualifications (PPAPs) for purchased parts• Collaborate with program managers to align sourcing and program management processes and streamline efficiency o Co-author of Haldex prototype part submission warrant form to expedite prototype approvals.

Milwaukee, Wi, Us

Ensured quality and regulatory compliance of motorcycle body and powertrain products• Outlined and completed AIAG compliant supplier part qualifications (PPAPs) for purchased parts• Ensured the quality of product and compliance of documents for multiple major supplier moveso Qualified all fasteners over to a new supplier• Managed supplier quality nonconformance and defective parts per million (PPM) reduction through 8 disciplines root cause analysis (8D) and corrective action request (CAR) completiono Decreased supplier PPM by 30% within 9 months and 70% over 18 months, achieving the lowest PPM rate ever for the site.• Ensured continuity of the supply chain utilizing SAP enterprise software to track inventory• Trained backup for Material Review Board to analyze and provide disposition for reported nonconformances

Chicago, Il, Us

Ensured quality and regulatory compliance of purchased metal, plastic, electronic, and architectural products• Outlined and completed supplier part qualifications for purchased parts• Utilized Gage R&R, capability study analysis, and Minitab control charts• Conducted ISO9001 and ISO13485 supplier audits across the USA• Trained a quality manager to become the main Hill-Rom lead internal auditor• Ensured the quality of product and compliance of documents for multiple major supplier moveso Drafted and executed a quality plan for transitioning all blow molded components to a new supplier, managing supplier onboarding, technical reviews, and supplier new part approval.• Managed supplier quality nonconformance and complaint reduction through corrective action/preventative action (CAPA)o Increased the supplier scorecards by 25% for top 3 commodity contributorso 25% reduction of confirmed supplier non-conformance reports.• Ensured continuity of the supply chain• Analyzed trending data for purchased product complaintso Implemented supplier change to eliminate complaints for hardness of Affinity® maternal line calf supportso Coordinated cross-functional meetings with architectural products suppliers, marketing, sourcing, and engineering to resolve color mismatches between wood and high-pressure laminates.

Chicago, Il, Us

Product quality engineer for the Affinity and Surfaces Assembly lines in the Batesville Operations facility• Ensured quality and regulatory compliance of finished productso Managed RoHS implementation via creating and executing a pilot protocol with my manufacturing engineer• Reviewed and approved engineering changes pertaining to each assembly line and corresponding products• Assisted with the review and closure of engineering complaint investigations for assigned products• Collaborated in the reduction of product nonconformances with the manufacturing engineers and operatorso Implemented master samples in the Surfaces welding department along with improving product workflow in the cutting department (via lean principles) to improve first pass yield and reduce nonconformances.• Analyzed trending data for product complaints using Excel and Minitab• Activities supported the closure of an FDA 483 warning letter• Managed three direct reports: monitored activities, completed APEX performance reviews and set employee goals• Conducted internal audits to ISO9001, ISO13485, and 21CFR820 standards as an auditor and as a lead auditoro Obtained certification as a Biomedical Auditor through the American Society for Quality

Louisville, Ky, Us

• Project Manager of the Tissue Structure Information Modeling (TSIM™) software product.• Aid in the development and design of the functional specifications for the TSIM™ software product.• Drafted the initial functional specifications document for TSIM™. • Plan lab tests and ensure quality of TSIM™ build cycles. • Partner in the advancement and incorporation of the science of 3D printed constructs in TSIM™.• Project Manager of the BioAssemblyBot (BAB) workstation product.• Collaborate in the mechanical and electrical design of the BAB.• Manage parts procurement and vendor contracts for BAB workstation components.• Assemble BioAssemblyBot workstations and test functionality.• Manage TSIM™ and BAB timelines as well as key milestones to ensure projects are delivered on time and on budget.• Interact with prospective customers to demonstrate the capabilities of TSIM™ and the BioAssemblyBot.

• Generated C++ code to accommodate the effects of drug delivery on cancerous tumor growth in 3D using mathematical modeling employed within the lab.

Union City, In, Us

Performed multiple job functions including operating the cash register, managing inventory, and delivering food to customers.

• Cultured and cryopreserved cell lines. Assisted with the clean room fabrication of carbon nanotube field effect transistors, and the process of testing the effects of specific binding of cells to the devices using a probe station, semiconductor parameter analyzer, and a LabVIEW interface. The specific binding of cells to the CNFETs was analyzed by comparing recorded source drain currents of experimental cell types to controls.

• Traveled as an ambassador for the company to the Cognitive Neuroscience Society annual meeting of 2012 with the Executive Vice President of Business Development to interact with potential customers and generate sales opportunities• Reviewed and archived clinical study documents under the tutelage of the Clinical Study Coordinator• Worked with Director of Production and Development to generate a user manual for the medical device as well as solutions for manufacturing optimization, software/electrical components debugging, and ergonomics • Assembled and tested multiple design iterations of the COGNISION® headset, now the first FDA approved ERP/qEEG device.

New Brunswick, Nj, Us

• Characterized astrocyte adhesion when introduced to different functionalized type I collagen substrates as part of a 10-week research program. The data obtained was then compiled for a research poster, presented during an oral presentation session, and then the research poster was showcased at the REU’s mini-symposium.

• Collaborated with faculty to create new policies that streamlined the business.

• Formulated standard curves of the wavelength absorption of chlorhexidine; results used for a drug delivery project with the objective of antibiotic and biofilm-degrading enzyme delivery from silk fibroin catheter coating to reduce catheter-related bloodstream infections (CRBSIs).

• Worked with the plumber to analyze the best ways to complete each job.

Master Of Engineering (Meng), Biomedical Engineering

Bachelor Of Science (Bs), Biomedical Engineering