STERLING MEDICAL DEVICES
The management team at Sterling Medical Devices is a group of highly experienced individuals who bring a wealth of experience and expertise to the company. Thanks to this group, Sterling remains one of the top medical device companies today.
Dan Sterling, President
Mr. Sterling has led the organization since its inception. Working with such prestigious organizations as McDonnell Douglas, Motorola, Honeywell and Guidant, Dan has managed software development processes spanning the aerospace, medical device and telecommunication industries. His experience with FDA and FAA regulations lends to the assurance that “best practices” are thoroughly applied in the development of the software. His diligence, dedication, and management credo, “do whatever it takes,” has been proven repeatedly, and consistently brings results to our clients.
Bruce Swope, VP of Engineering
With over 25 years’ management experience in medical device software development, Mr. Swope possesses exceptional knowledge of the medical device and software industries from both a business and technical perspective. He has successfully managed software development teams of up to 150 people, and he is an expert in leading Class III medical software products to commercial release. His depth of experience also spans the development of enterprise solutions, security applications, internal applications, and process control systems. Integral to these efforts has been his early adoption of quality practices including ISO 9000 processes, Common Criteria Certification and Capability Maturity Model implementation.
John Campbell, VP of Quality
With over 30 years’ management experience and over 20 years in medical device development, Mr. Campbell has exceptional knowledge of the medical device industry. He has successfully managed teams involved in product development of Class II & III medical devices, test system design, test automation, process development, process automation, and electronic documentation system development. He led a Director-level team in a complete re-write of 1000+ person company’s SOP’s to bring them into compliance with 21CFR820 and ISO 9001. His years of experience also include terms as Site Quality Assurance Manager, Quality Assurance Engineer, Integrated Circuit Receiving Inspection & Test Manager, Quality Control Supervisor, and Manufacturing Supervisor.
Larry Bischoff, Embedded Systems Manager
Mr. Bischoff brings two decades of product development experience, in both product management and engineering roles to the organization. Working in both the medical and military industries, he has gained a wealth of knowledge and experience in electronic hardware design and leading product development from concept to production. Through the course of his career, Larry has been responsible for the development of suppliers providing parts and sub-assemblies of all types including injection molded parts, fabricated plastic, and metal enclosures, electronic components, cables, PCBs and turnkey assemblies. Larry has over 15 years of experience in R&D of class II and class III medical devices with customers ranging from major corporations to start-up companies. He has led all phases of design for a variety of complex medical devices including neuro-stimulators, left ventricular assist systems, ECG monitors, RF charging systems, and many others.
Erik Hilliard, Director of Business Development
Mr. Hilliard has been developing high-quality medical devices for the last nine years as a member of the Sterling Medical Devices engineering staff. As a trained Computer Engineer, he has developed, tested and managed projects consisting of implants, diagnostic, and therapeutic devices. He has worked in many different environments while working with many different development languages. He brings a particular client focus to every job ensuring client transparency that the project is being done right the first time. Along with his experience in the finance, telecommunications, and business to business fields, he brings a varied skill set and perspective to each project.
Carrie Hetrick, Director of Regulatory Affairs
Carrie has been involved in medical technology for over 20 years, focusing on the intersection of technology, regulation, and health care and have led numerous quality management and business process improvement/ management measures. She has led consultancy regulatory, clinical, and quality business, focusing on helping emerging companies navigate challenges in product development while establishing appropriate clinical, regulatory, and compliance structures. Her expertise in regulatory and clinical affairs led to several successful regulatory submissions and clinical trials in the US and Europe. She is a seasoned subject matter expert in taking new products from R&D to the medical market. Her extensive international experience has helped companies navigate the regulations, providing expertise piloting regulatory, clinical, and operational challenges facing each stage of development. She has proficiency in leading early and late-stage cross-functional medical product development programs, directing activities and teams for all phases of design controls, and creating collaborative and productive alliances with partners.