Business Development Consultant For Medical Device Manufacturer

REGULATORY COMPLIANCE ISO, FDA CERTIFICATIONS

• ISO 13485:2003

• ISO 9001:2008

Since 1996

Woman owned

100% Made in America

Our company's Engineering has a substantial amount of experience with medical device product development, technology development, project management and manufacturing. Our inhouse design and manufacturing of complex precision machined components and final product assembly meets customers development and production needs. We can manage a project through the entire project life cycle-from prototype through full-scale production. Our founder was also a Co-Founder of Symbiosis Corporation (Founded in 1985) a leader and pioneer in the emergence of disposable medical instruments. Symbiosis introduced disposable instruments in two areas of treatment: Low-cost biopsy forceps that were marketed through Microvasive, a subsidiary of Boston Scientific Corporation, and Laparoscopic instruments that were marketed through Ethicon Endosurgery, a Johnson & Johnson subsidiary.

PROJECT MANAGEMENT

When a project is entered into the Manufacturing data base, an engineer/project leader is selected to manage and implement a project from concept/customer design specifications through commercialization to the customer. The project leader remains accountable for each project through the project or product life cycle. Project leaders are responsible for design for manufacturing and target pricing.

TECHNOLOGY DEVELOPMENT

We have a substantial amount of experience with enabling technology development for multiple medical device specialties.

It all starts with a customer’s 3D model from a 3D modeling program such as Solid Works or ProEngineer. Our company converts the customer’s product geometry into CNC machine code utilizing various computer automated manufacturing software programs. Customer prototypes are quickly produced through a fully staffed tool-room, and rapid printing and prototyping systems. Engineers generate CNC programs, design manufacturing tooling and quickly integrate new manufacturing processes into selected production centers. Measurement systems and test methods are also developed to ensure first article inspection dimensions and specifications requirements are met.

Manufacturing methods and equipment are designed in-house with a special emphasis placed on Lean manufacturing and Six Sigma methodologies. Equipment is designed for standardization, and modular set-up. Engineers and machine operators participate in the design, programming and set-up of 5-axis CNC Milling, Swiss CNC Turning, CNC Multi-Axis Grinding and secondary processing operations. Our company utilizes Lean Design andManufacturing methodologies, and determines the most efficient and cost-effective methods of manufacturing.

Long-term manufacturing agreements enable year-over-year savings for our customers. These savings are achieved through continuous improvement, and year-over-year efficiency gains.

• Endoscopy Biopsy Forceps

• Endoscopy Surgical Devices

• Laparoscopic Electrosurgical Devices

• Cardiovascular Devices

• Stent Delivery Systems (Balloon expandable and self-expanding Nitinol stent delivery systems)

• Stent Manufacturing

• Guidewire Manufacturing

• Cardiovascular Biotomes

• Artherectomy Devices

• Cardiac Surgery Instrumentation

• Ventricular Assist Devices

• Rhythm Management and Defibrillation Devices

• Abdominal Aortic Aneurysm (AAA) Devices

• Endovascular Devices

• Neurovascular Devices

• Orthopaedic Trauma Products

• Orthopaedic Plate and Screw Systems

• Small and Large Bone Plate and Screw Systems

• Intramedullary Fixation Devices

• Dental Implants

• Swiss CNC Turning

• CNC-3-5 Axis Milling

• CNC 8-Axis Grinding

• EDM and Wire EDM

• Titanium Anodizing

• Laser Marking

• Laser, TIG and MIG Welding

• Electropolishing

• Metal Polishing and Finishing

• Heat Treatment of Metals

• Micro-Bead Blasting

• Passivation

• Bending and Forming

• Clean Room Assembly

• Manufacturing Documentation

• Manufacturing Scale-up

• Design and Product Transfer to Customers

• Test Method Development and Validation

• Product and Process Validation

• Lean Manufacturing

• Six Sigma Methodologies

Candidate Profile: At least 10 years experience selling to or working with medical device manufacturers of all sizes including start ups looking for engineering and prototype work.  Relationships with surgeons and device r&d labs extremely helpful.

Training required: Marketing collateral and in-house technical experts.  No technical expertise required on your part, just open the door for us. We are looking for someone to generate leads, open doors, use their contacts to get us to the right people, and we'll take it from there.