Leading team and extensive partner networks in developing proprietary pulmonary devices under Design Control regulations, managing electrical, mechanical, software, and data science activities. Identifying, formulating, and supporting research, clinical, and training activities. Maturing early-stage company's processes and tools.

Transitions medical devices from research through development. Functions primarily as a project lead or systems engineer. Provides early upstream marketing, business development, and customer interaction. Addresses key research questions followed by user needs, product requirements, preclinical evaluation, clinical hazards, usability and human factors, verification, validation, and preparation for clinical studies. Provides technical expertise in physiology, biomechanics, study design and statistics, data analysis, and mechanical design.

Acted as chief engineer for startup projects. Roles included managing projects, interviewing customers, defining user needs, product requirements and specifications clinical hazards, regulatory requirements, human factors and usability, FMEA, UFMEA, verification, validation. Performed modeling, mechanical design, prototyping, and bench testing of devices; preclinical evaluation, statistical analyses, and clinical studies. Developed devices for radiofrequency catheter ablation and orthopedic surgery. Coauthored successful SBIR grant. Developed company quality (ISO 13485, CFR 820) and risk management systems (ISO 14971). Wrote quality manual and SOPs, such as design control, risk management, and supplier evaluation.

Conducted preclinical evaluations of medical devices and combination products. Led cross-functional teams to assess customer needs, address key technical questions, provide regulatory data, validated software, and/or train physicians for medical device research and development for diabetes, spinal, and ablation technologies. Leveraged Lean Six Sigma and SMART objectives for continuous improvement.

Conducted and managed staff for preclinical evaluations of medical devices and combination products. Managed professionals and established department performance standards. Managed project teams, conducted cardiac research, collected and analyzed data, filed patent disclosures, generated animal models, and published results; multiple performance nominations and awards. Facility Net Promoter Score increased from 30 to 70 during tenure.

Conducted preclinical evaluations of medical devices. Led cross-functional teams, addressing key technical questions and providing regulatory data for Class III implantable medical devices, including cardiac pacing & defibrillation along with neurostimulation. Implemented a data management system handling $10 million/year in transactions.

Conducted animal research assessing means to reduce the defibrillation threshold, using Matlab to program a custom waveform generator (6 publications). Acted as the company finite element analyst, including meshing of an anatomical heart model.