As a Medical Device Development Consultant, I perform product development services for medical OEM companies specializing in managing projects and engineering design of medical products. Services include project management, mechanical engineering, plastic part design, medical polymers/metal knowledge, electro-mechanical design, and medical packaging design. Design utilizing SolidWorks as a 3-D design tool. Project Management: I work with Teams to manage successful projects from conception to production. Manage projects using FDA 21 CFR 820 and ISO 13485 Design Controls guidelines, of which, compile Design History Files and input Technical Files, including generating project plans, product specifications, PDP's, PRDs, task scheduling, risk and hazard analyses (dFMEA's), Human Factor Engineering & User Studies, V & V test plans, process validations, and product labeling. Prepare documentation for FDA 510(k) submissions.Product development of OR/ER instruments, electrosurgical/surgical devices, laparoscopic instruments, syringe systems, infusion and intravenous devices/catheters, silicone catheters, tracheal tubes, respiratory devices (masks, connectors, and catheters), urology devices, oximetry probe, orthopedic products, epistaxis devices, dental products, fluid drainage products, pulmonary therapeutic devices, medical kits, and various other medical devices.Medical packaging design of thermoformed trays, pouches, bags, lidded trays, form-fill-seal, blister packs, and cartons for sterilization methods: EtO, gamma, E-beam, autoclave. Electro-mechanical packaging utilizing plastic and sheet metal designs, graphic overlays, LCD displays, switches, and bezels/panels.

Project management of a medical product Vibralung Acoustical Percussor used in the treatment of pulmonary atelectasis, and provides Airway Clearance Therapy (ACT) to enhance mucokinesis. As Project Manager my Responsibilities included product development and design, managing the DHF activities, defining risk analyses, project scheduling and task coordination, product development plan, product requirements and specifications, V & V test plans, and coordinating Team activities.I continue to work with company Teams to develop various respiratory products and manage their Design History Files.

Project Manager and Mechanical Engineer for a unique dual-chamber syringe system for medical IV applications. Responsibilities include managing the project and company resources, and preparing a Design History File for FDA 510(k) submission and future production.Alpha design of humidifier device used in therapeutic respiratory equipment. Responsibilites included plastic part design, and documenting a Design History File, and creating a workable prototype.Project Engineer and designer of the MidPro Extended Dwell Catheter, a midline catheter for intravenous access used for aspiration of blood specimens and non-caustic IV fluids. Project Engineering responsibilities included managing the project, component plastic part design, specifying components of the assembly, and compiling a DHF. Evaluate syringes and create test plans for qualifying syringes to be used by diabetic populations. Design of syringe sheaths, and performed various mechanical tests of syringes.

Design Engineer activities in the development of a unique syringe plunger system for their SiO coated 1 mL pre-filled syringe, and management of the project Design History File. Responsibilities include piston and plunger rod design, data analyses, User Study, and tasks to compile a DHF. Design activities and project responsibilities to release a 3 mL disposable syringe, plunger rod, and piston system for FDA 510(k) approval.

Product development of hair follicle placement devices for hair transplants. Devices include: Dull Tip Punches (reusable & disposable), Rotary tool, Follicle Implanter device, Probe Sheaths, Depth Indicators.Developed and released to market the SafeScribe blunt dissecting punch for hair follicle removal. Performed function as Project Engineer and Mechanical Designer for the stainless steel surgical device. Designed various other surgical tools for hair follicle removal and transplant.

Mechanical design of prototype delivery handle for the Medusa Vacular Plug, which is an implantable device for vacular occlusion. Responsibilities incuded providing handle concepts and subsequent design for the development of a prototype handle that could be used in clinical trials. I worked with a Team to aid in bringing this device to the medical field.

Perform testing as part of an accelerated aging study on 500 ml and 1000 ml PETG vacuum bottles used for pleural fluid drainage of patients. Diagnose challenges of production vacuum bottle equipment in Dominican Republic plant. Worked with a Team of Engineers to bring 4 vacuum bottle sealing machines into production at the Dominican Republic plant.

Mechanical design of a Transurethral Suprapubic endo-Cystostomy urological instrument for positioning a supra-pubic catheter. Responsibilites include mechanical engineering, plastic part design, supra-pubic catheter design, assembly documentation, testing, and manage suppliers to meet product goals. Apply knowledge into input to user requirements, device specifications, risk analysis, polymer/metal material requirements, and test plans. Mechanical design of a unique urological accessory instrument for minimally invasive surgery to access the bladder.

Development of an innovative endotracheal tube stabilization system. Activities include design and testing of the endotracheal tube and tube stabilizer. As Project Manager I managed a Design History File, worked with the Team on Design Controls activities, and worked to implement the devices into production. Generated project plan, product requirements and specifications, risk analysis, test plans and protocols, and performed design reviews and supplier coordination activities.

Design and testing activities of an Airless Pressure Pod that monitors blood flow pressures used during dialysis.Design activities for Fresenius Medical on saline/PD bag injection site and spike port. Design Engineer working with Fresenius Medical Care on analyzing and recommending designs and polymers for a cassette spring used in fluid transfer.

Performing a manufacturing engineering function to bring 13 injection mold tools up to an operational state to produce production parts for several electrosurgical devices. Responsibilities include working with a molder and coordinating IQ, OQ, and PQ activities.

Developing an innovative medical device used in gynecology. Design is from conception to final production including packaging.

Consulting Engineer on the Pleurex therapeutic drainage kits of vacuum bottle and catheter system. Responsibilities include mechanical design, test, and implement into production for Dominican Republic plant. Products are used for cancer patients in managing recurrent pleural effusions.Consulted in setting up vacuum bottle sealing equipment in production for evacuation and sealing of the bottle.

Designed various configurations of infusion pump tube sets for the Tritan Infusion Pump.

Designed the OS Holster and Clamp, which is a unique safety holster device for use in surgery. Product is an injection molded device to hold instruments and keep them from being contaminated. Named on design patent for the device.

Developed an endotracheal tube stabilization system to prevent unplanned extubations. Responsibilities included generating design specifications, DFMEA, and part designs, which included injection molded adapter, face plate retention piece with strapping. Consulted on performance requirements, regulatory issues, material requirements, and supplier management.

As a Project Engineer, I managed projects of various surgical kits for the placement of Pleurx Catheter used for managing pleural effusion fluid in cancer patients. Responsibilities included creating design specifications, sourcing components, V & V testing, input DFMEA, packaging design (lids and trays), and performed design reviews. Coordinated with manufacturing for implementing into cleanroom production area. Developed a 500 ml and a 1000 ml blowmolded vacuum bottle and catheter system with access dilator used for fluid drainage in the Pleurx product line. Development tasks were performed from conception to production, and implementation into manufacturing.Production support of surgical kits and catheter products, including implantable silicone catheters and shunt valves, percutaneous access products, and the Pleurx product line. Researched, procured, and validated a heat sealing machine used for sealing Tyvek lids to thermoformed trays. Designed various trays and lids, and pouches for catheter kit products and implemented into production. Designed the heat sealing plates and nests.Project Engineer and Mechanical Designer of the Biopsy Assistant, a biopsy needle product used for stabilizing nodes for surgical removal. Responsibilites included creating concepts, design specifications, plastic and metal part designs, specifying molders/suppliers, V & V testing, IP management, packaging (lid and tray), and performed design reviews.Completed successful redesign of the ParaPro 1200 paracentesis needle for fluid drainage. Solved mechanical challenge in preventing reuse of the device.

Designed various baby bottle products incorporating into the Second Nature product line, sippy cups, bottle nipples, pacifiers, sterilizing device, bottle cleaning brush. Utilized experience in blowmolding, injection molding, knowledge in rigid polymers, silicone and other elastomerics. Developed manufacturing fixtures used for China manufacturing.

Developed the Cadence Transtracheal Catheter and Mid-Section Hose, which is a high-flow catheter system and an connective in-line tube set for weaning patients off of a ventilator. Responsibilities included plastic part design, materials research to meet biocompatibility requirements, DFMEA activities, V & V testing, assembly documentation, and packaging design for EtO sterilization. Responsible for compliance with FDA Design Controls requirements and documenting a Design History File. Worked as a Manufacturing Engineer in implementation into production, specifying assembly equipment, and generating manufacturing process documentation.

As Principle Investigator on three NIH-SBIR funded projects, I developed Phase I and Phase II prototype medical products. Technical writing of NIH-SBIR grants for five innovative medical products. Performed bench tests and assisted in human trials.Designed, prototyped, and tested an inflatable epistaxis device for controlling hemorages of the nasal passage.Designed, prototyped, and tested an inflatable (SOC) device for controlling venous insufficiency of the lower leg.Designed, prototyped, and tested a reusable diabetic foot/leg cast, and developed a fluid filling system for the purpose of conforming to the foot/leg anatomy. Named on design patent for this device.

Designed a syringe system for blood sampling with responsibilites in injection molded part design, material recommendations, tooling requirements, ultrasonic welding application, pad printing. Compiled a DHF with specifications, DFMEA, suppliers, manufacturing and drawing documentation.Design of a powered percussor device used for respiratory therapy in persons with phlegm producing conditions.

Development and design of unique respiratory masks and tracheal guide tubes used for emergency and trauma patients. Responsibilities included developing user requirements and design specifications, DFMEA, and plastic part designs. Coordinated with other companies to adapt these devices with use of an endoscope.

Designed various respiratory catheters used of delivering oxygen to patients, custom oxygen relief valve, mechanical design of switching mechanism for portable oxygen delivery unit, introducer connector for tracheal catheter, and various oxygen catheter connectors.

Design of a catheter system for endotracheal intubated patients for continuous ventilation with suction capability. Designed a pop-off relief valve for a heat/moisture ventilator unit.

Designed the Atrisorb kit, a dental prep kit for treatment and healing of gum disease by means of a polymer barrier. Designs included a hinged plastic prep case, and Porex saline absorbent tray, and product packaging. Recognized in Medical Product Packaging periodical for the packaging design. Designed a syringe system used for delivering polymer directly to the surgical site.

Designed handcontrol pencil used in electrosurgery with responsibility in designing the injection molded housings.

Designed the Cord Blood Collection System, which is a non-invasive plastic part device that collects umbilical cord blood samples safely and efficiently, and dispenses the blood into sterile tubes. Designed the pouch packaging for EtO sterilization.

Developed electrosurgical products, including mechanical design of the DANA 800 clinical electrosurgical generator, handcontrol device, and disposable patient ground pad. Wrote and received 510(k) for disposable patient ground pad. Named on design patent of innovative reusable handcontrol device.Biostar, Inc. - Electro-mechanical package design of the Strep A OIA Test Work Station used for analyzing strep culture samples. Mechanical design responsibility for plastic housing/back panel, graphic display overlay panel, battery chamber, and PCB mounting.

Mechanical Designer of electrosurgical equipment, including electro-mechanical packaging of two surgical generators. Accessory device development included cautery/coagulation handcontrol pencils, foot-control pencil, suction handcontrol device, smoke evacuator handcontrol, safety cup holsters, laparoscopic instruments, surgical electrodes, RF cable accessories, and other surgical devices.Performed Mechanical Engineering function on the Argon Beam Coagulator (ABC) surgical generator as lead engineer of the electro-mechanical packaging. Designed ABC disposable and reusable accessories for general surgery, including a dual function laparoscopic device, a handcontrol and footcontrol device, and ABC nozzles. Worked with manufacturing to implement these accessory products in Juarez, MX plant. Named on patents for innovative laparoscopic instruments.Lead Mechanical Designer for a blood pressure monitor unit responsible electro-mechanical packaging of the electronics, chassis, and front panel mechanical design.

Mechanical engineering and design of a reusable oximetry finger probe responsible for determining the mechanical operation, plastic part design of the probe housing, cable interface, cushion design, LED assembly, and spring clip design.