NuPulseCV is a clinical stage, cardiovascular medical device company with a focus on heart failure therapies. My current responsibilities include design and development of products and tools, manufacturing development with some manufacturing of clinical product, supplier management, management, processing and validation of EO sterilization, management and review of returned product, verification and validation activities, and quality system development.

Respirion is developing capnography devices (measure CO2 and respiration rate) for the medical marketplace. Designed commercial ready version of a capnography device with a main & side stream version. Prototyped designs for trials and studies and participated in the studies. Performed and managed verification and validation activities including IEC 60601 approval. Task performed included device design and development, prototype manufacturing, project management, risk management, supplier management, regulatory review, verification and validation, regulatory filings and quality system development.

Oncoscope is developing an optical screening platform used to instantly identify dysplastic or pre-cancerous tissue for biopsy using Angle-resolved Low Coherence Interferometry (a/LCI). I was responsible for mechanical design and development of devices and for manufacturing engineering of such devices.

Gilero is a leading provider of pharmaceutical and medical device design & development services from concept to commercialization. I was responsible for design, development and prototyping of various medical devices. Some of these devices included safety syringes, vial adapters, humidification for ventilation, and drug storage containers. Wrote provisional patent applications for several designs.

TransEnterix provides and develops single port laparoscopy surgical devices. Coordinate and track the design and development projects for the company. Interface with suppliers and key outsourced technologies to ensure projects meet schedules. Facilitate the completion of documentation needed for FDA 510(k) submission of devices. Help transition devices from development into manufacturing.

Developing manufacturing processes, quality systems, and managing facilities for a start-up company making a single port system for Laparoscopic procedures.

InnerPulse developed vascular devices for treatment of arrhythmias or abnormal heart rhythms. Developed manufacturing process (paralene coating, hydrophilic coating, silicone and polyurethane jacketing, packaging, and sterilization), quality system development, and managed facilities for the company.

Robling Medical (was Apogee Medical) is a full service contract medical device manufacturer. Managed engineering and maintenance departments.

Teleflex is a global organization dedicated to supporting healthcare providers with a broad range of medical solutions. During the last year with TFX I developed urinary and respiratory products. Early career was with the Weck product lines (surgical staplers and ligation clips).

The NRC regulates commercial nuclear power plants and other uses of nuclear materials. Inspector and mechanical engineer for US Nuclear Regulatory Commission.