MFG Design and Operations Director
Mark has over 30 years in the medical device industry, with experience in new product development, manufacturing design and process optimization including automation, material management, and capital and consumable manufacturing. Mark has contributed to multiple proprietary medical device designs, from “napkin” through product development under FDA 21 CFR 820 Design Controls, design transfer, and low- and high-volume manufacturing transitions. Mark has a keen ability to identify clever design and process solutions that result in efficient and effective solutions, ultimately improving manufacturability and lowering COGS. Having worked together for over ten years, Stephanie Harrington routinely looks to Mark for his responsive and clever “MacGyver” solutions.
For the past 5-10 years, Mark has had increasing managerial positions in manufacturing, most recently serving as Director, Manufacturing, Frantz Medical Development. As an ISO 13485 certified and FDA-registered facility, Mark ensured the highest quality production while maintaining compliance to Quality System Regulations (QSR). In addition, several of Frantz Medical’s most recent new products and process improvement initiatives have included automation integration, optimization and qualification, for assembly, in-process inspection, and liquid filling and sealing operations. As a core operations team member, Mark worked closely with Quality and Regulatory in ongoing post-market and operational activities, such as Management Reviews, Corrective and Preventative Actions, Non-Conformance Reports, and Internal and External Audits.
As Manufacturing Design and Operations Director at Matrix, Mark provides Matrix Clients with guidance and expertise for new product development, manufacturing optimization (processes, fixtures), supplier recommendations (components, manufacturing services), troubleshooting (improving yield, vendor issues) – as well as assisting the Client with preparing applicable QSR-compliant documentation. As an experienced SolidWorks CAD designer, Mark provides CAD models and drawing packages for Matrix and its Clients. Mark is also responsible for Matrix Operations, including the Matrix FDA-compliant Product Development Laboratory and Manufacturing, e.g., new test equipment identification, incoming qualifications and ongoing preventative maintenance and calibration. In addition, Mark oversee the Matrix Facility, including space layouts, Client requests, and utility/mechanical improvements.