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.
• 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.

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.
• 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.
• 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

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%.
• 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.

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.
• Analyzed trending data for product complaints using Excel and Minitab

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.

• 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.

• 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.
• 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.

• 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.

• 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