Our Team of Medical Device Experts

The Sterling Medical Device team is an expert group of medical device makers with years of experience in engineering and medical device development. Our leadership and hard-working team members have earned us a strong reputation as a top medical device company.

Learn More About Our Expert Medical Device Makers

Dan Sterling, President

Mr. Sterling has led the organization since its inception. Working with a wide range of companies that make medical devices as well as prestigious organizations such 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 30 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 of 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 of medical device makers 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 team of medical device makers at Sterling Medical. 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 management 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 with companies that make medical devices for over 20 years, focusing on the intersection of technology, regulation, and health care and having 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.

Steven Hartman, Engineering Manager

A member of Sterling Medical Devices since 2012, Steven Hartman leads the project management team on some of the firm’s most technically complex projects, with a focus on novel device development. Given his passion for doing work that saves lives, Mr. Hartman has committed his career to helping his clients launch products that make a difference in society. In his more than 25 years of experience in the medical devices field, Mr. Hartman has learned to appreciate the value of slowing down to read, learn and understand what’s needed to build a strong team and guide his clients toward life-saving innovations.

Jamme Tan, Project Manager

Jamme Tan is a Project Manager with Sterling Medical Devices, where he oversees project rescues and new device development and collaborates with clients to develop solutions to address their unique challenges. Mr. Tan joined the team in 2004—and has since consistently worked his way up the organizational ladder. One of the company’s most dedicated employees, Mr. Tan has spent the better part of the last 16 years cultivating his software engineering expertise in electronics, firmware and mechanicals, and has played a crucial role in the development of wearable and implantable devices. Mr. Tan derives tremendous value from his work, secure in the knowledge that the solutions he develops offer remarkable benefits to the individuals who need them.

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Nick Oshman, Quality Assurance Director

Nick Oshman is the Quality Assurance Director for Sterling Medical Devices, where he partners with clients to ensure materials, parts and products comply with established quality standards and government regulations. Mr. Oshman is a skilled decision-maker who has mastered the ability to understand his clients’ pain points and develop solutions that help them overcome obstacles and save lives. Prior to joining Sterling Medical Devices as a Verification Engineer, Mr. Oshman spent the early part of his career testing software and cultivating deep expertise in the area of systems engineering.

Ben Holt, Engineering Manager

As the Engineering Manager for Sterling Medical Devices, Ben Holt is primarily focused in the area of digital guided surgery and imaging, a discipline that aids in the mapping of surgical scenes. Since joining the team in 2006, Mr. Holt has earned notoriety among his teammates and clients for his creativity and technicality—a combination that allows him to think on his feet and turn the information he learns into agile developments that can be applied to medical devices. He is equally as committed to managing people as he is to managing project and empowering his teammates to achieve their goals.

Resources

Nick Testing Web

February 7, 2018

Hazard Analysis

Role of Hazard Analysis in ISO 14971 Medical device hazard analysis is a fundamental requirement of ISO 14971 risk management. Hazard analysis entails identification of hazards from possible...
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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people developing a product

November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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