Akura Medical, Inc. is a portfolio company of Shifamed, LLC., a highly-specialized medical innovation hub focused on developing advanced solutions that get to market faster, reduce risk, increase impact, and forge a path toward a world where all people are able to lead longer, healthier lives. Akura Medical is focused on Next-Generation Thrombectomy providing effective and easy-to-use clot removal to efficiently treat venous thromboembolisms.

Head of Operations & Quality at Avive Solutions, Inc. a San Francisco-based privately held healthcare technology company developing a next generation automated external defibrillator (FDA Class III, PMA Medical Device) and software solutions in an effort to significantly increase survival rates from Sudden Cardiac Arrest. In this role, Eric was responsible for manufacturing and quality management system implementation and maintenance, strategic planning, and operational compliance in preparation for the company’s next generation automated external defibrillator PMA submission.

Potrero Medical, Inc., spinout of medical device incubator Theranova, LLC, is headquartered in San Francisco, CA and was founded with a mission to improve outcomes, reduce costs and expand access to healthcare. Accuryn™ is a critical care monitoring system that transforms the traditional urinary catheter into a next-generation diagnostic tool. Accuryn uses proprietary electromechanical designs and advanced software algorithms to deliver automated, real-time actionable data including urine output, core temperature and intraabdominal pressure. In this position, Eric was instrumental in building the initial prototypes, scaling the engineering and manufacturing team, and executing through design transfer and U.S. launch of the company’s Accuryn™ Critical Care Monitoring System.

Held direct leadership for manufacturing engineering during critical rapid growth associated with European market ramp, IDE clinical trials, preparation for FDA PAI/PMA and U.S. launch of MitraClip system (Class III medical device) used by interventional cardiologists to reduce mitral regurgitation, adapting open surgical double-orifice technique in less invasive, catheter-based procedure. Led sustaining manufacturing engineers, project engineers, advanced manufacturing engineers, equipment design engineers, process validation engineers, packaging engineers, and design for excellence master black belt engineer. Held responsibility for department recruitment, staffing, performance appraisals, as well as succession planning for number of employees in excess of 50. Achieved reduction in reoccurring NCR’s, labor hours, cost, scrap, improved yield, ergonomic and safety, lean initiatives, resolved supplier quality & supply chain issues. Led site process validation remediation - assembled engineering team to perform more than 75 process validations including IQs, OQs, PQs, PPQs, and performed the role of subject matter expert directly with FDA auditor resulting in zero findings and successfully passing the FDA pre approval inspection. Protocol and report reviewer and approver on all site validations including facilities, design, software, test method, process, packaging, cleaning, sterilization, aging/shelf-life, and supplier. Led CAPA’s associated with reliability, design, process, quality system, supplier, packaging, facilities, field action/recall. QSIT team member, led numerous audit readiness initiatives, member on multiple quality boards such as risk management, change control, CAPA, management review, Abbott Quality Regulatory (AQR) readiness. Project Review Board (PRB) founding member developing a system for successful prioritization, execution and tracking of site CAPA’s, projects, and department initiatives.

Led manufacturing operations as first manufacturing employee, employee number 12, to develop the XTENT Custom NX Drug Eluting Stent Systems with Biolimus A9 and biodegradable PLA (FDA Class III PMA Medical Device), achieving CE mark and IDE approval. Performed as individual contributor until plan warranted hiring direct reports, and gradually built team which exceeded 115. Held direct leadership for manufacturing engineering, manufacturing, equipment design and development, packaging, facilities, and EHS. Responsible for department budgeting, process engineering and development, design control deliverables, manufacturing readiness, CAPA, supply chain and supplier quality engineering initiatives, capacity planning, scheduling, metrics reporting, facility expansions, plant design and construction. Developed and implemented systems, such as ManufactPro integrated document database system, QAD ERP system, process monitoring systems, lean manufacturing and world-class manufacturing initiatives.

Led manufacturing and packaging engineers on product development teams through design control process to market release. Managed engineering projects to improve quality, reliability, yield, throughput, and reduce scrap. Directed CAPA root cause analysis, corrective action, preventive action. Knowledgeable on the following products: abdominal aortic aneurysm (AAA) device (pre-acquisition company Endovascular Technologies, EVT), peripheral braided stent, next generation AAA delivery system and implant (unibody graft and staged graft), sheath, AAA graft projects, saphenous vein harvesting device, automated anastomosis system, and pacemaker leads. Served as team leader during quality remediation initiative following FDA product recall. Process validation gap analysis (approximately 45 IQ, OQ, PQs, and 22 software validations) and re-validation execution. Planned plant relocation Puerto Rico transfer, new process flow layout, cellular manufacturing methods, as well as DFT. Managed department budgets, plans, schedules, reports, recruiting, performance appraisals, and succession planning for number of employees in excess of 10.

Developed proprietary technology to create an automated anastomosis system for the attachment of coronary artery bypass grafts (CABG) during either conventional, minimally invasive, or beating heart coronary artery bypass surgery. Worked on product and process innovation, equipment design and development, process engineering, DOE, pilot line development and manufacturing training.

Pre-acquisition company Progressive Angioplasty Systems (PAS). Led catheter technology development and pilot manufacturing group in collaboration with radiation, balloon and stent groups. Held responsibility for delivery system manufacturing engineering, sustaining line support, ongoing troubleshooting, capabilities studies, process validations, SPC, ECNs, BOMs, SOPs, assembler and lead training. Responded to non-compliance issues, customer complaint investigations, discrepancy reports, material review boards, and CAPA’s. Oversaw capital and expense budgets. Contributed to competitive product performance testing and analysis. Responsible for number of employees in excess of 10.

Served as employee number three for a start-up company which designed, manufactured, and sold devices for cardiology, hemodialysis, OB/GYN, intensive care therapy, and other clinical markets. Built a team (recruited, hired, trained, supervised, motivated, inspired) operating a class 100,000 cleanroom three shifts, 24 hours per day, six days per week, for number of employees in excess of 80, producing over 200 finished product codes. Held responsibility for product development, pilot manufacturing, production planning, supply chain, purchasing, manufacturing, sustaining engineering, proprietary processes/equipment/jigs/fixtures/tools, facilities, IT, physical plant layout, expansion construction projects, PM and calibration, employee handbook, (company policies).