Successfully received FDA Breakthrough designation for an innovative place-and-scan fetal cardiac monitoring device. Created, submitted, and managed DeNovo and 510k submissions for electromechanical devices. Developed multiple Regulatory Strategies to enable medical device market authorization. Leveraged FDA Q-Submission process to gather feedback from FDA prior to premarket notification to verify planned regulatory path.

Responsible for the direct oversight of the Program Management group at ERI with 4 direct reports. Managed project health assessments and reporting for the Development business unit. Focused on mitigation of project health issues when present. Drove business development efforts including initial client contact, project scoping, project cost/timeline estimation, and final client price negotiation.

Led a full development program for a complex, multidisciplinary ultrasonic imaging device and its companion disposable. Directed a multidisciplinary project with over 9 FTE resourcing within the home-based dialysis sector. Successfully balanced client needs with internal company resource shortage to maintain the agreed upon project deliverables and timeline.

Created design concepts for medical device mechanical systems including VHF ultrasound and thermal imaging. Utilized rapid prototyping techniques to test and communicate designs with clients in an accelerated manner. Worked with clients to ensure design requirements were met. Facilitated transfer of design to manufacturing (both domestic and overseas).

Each year, I advise a graduate product design group within the Department of Mechanical Engineering's Graduate Design Program.

Developed engineering specifications and design concepts for intravenous (IV) infusion pumps and disposable administration sets. Determined user needs and associated product requirements through direct observation and discussion. Authored V&V protocols and reports associated with product improvements. Directed technical support staff regarding execution of V&V protocols. Created, updated, and maintained project plans. Lead and participated in design review meetings. Conducted risk management including Design Failure Modes and Effect Analysis (DFMEA). Drove various Corrective and Preventive Actions (CAPA).

Acted as Product Engineer, Sustaining Engineer, and Manufacturing Engineer for three disposable Active Electrode Monitoring (AEM) product lines. Developed and implemented V&V activities associated with outsourcing of product components to reduce overall COGS. Led various Corrective and Preventive Actions (CAPA) which reduced overall scrap of the Disposable Fixed Tip Electrode product line by 8%. Served as lead operations representative for the transition and launch of a new product from development. Also conducted failure investigations, root cause analysis, and executed supplier quality audits.

Investigated a non-DEHP plasticizer alternative for use within automated collection apheresis (blood component separation) disposables. Developed a verification plan to test passive tubing within three different disposable sets used on the Trima®, Optia®, and Reveos® platforms. Conducted design reviews while adhering to phase gate design controls.

Surveyed a wide variety of polymers and determined which material properties were most significant for use as a jaw liner material for the Sonicision Cordless Ultrasonic Tissue Dissection System by using Minitab software to conduct statistical analysis of data (correlation analysis, stepwise regression, and general regression). Designed, fabricated, and developed multiple test procedures for jaw liner experimental setup which included thermal imaging analysis. Identified multiple candidate materials as a result of the jaw liner study which improved product performance and reduced operating temperature by approximately 200°C, material cost by 20%, and eliminated one design component from the Sonicision device.

Redesigned, fabricated, and successfully completed five live human surgical trials of a novel endomechanical instrument that measures peristalsis in the human small intestine. This force has not previously been experimentally measured in a human and serves as a critical design parameter in the development of Robotic Capsule Endoscope (RCE) technology. Collaborated with medical faculty to translate user needs and sterile O.R. requirements into device design features compatible with laparoscopic Roux-en-Y Gastric Bypass surgery.Please follow the link or click the thumbnail to see a video of one of the live human trials of the device. https://youtu.be/ohz6Uu0o4Rk

Conducted all interviewing, hiring, and training activities for a department with over 30 student employees.

Conducted a field study quantifying the effectiveness of a medical brace designed to off-load heel strike in patients with ankle arthritis. Analyzed data which resulted in quantization of device effectiveness yielding an average 30-100 pound heel strike reduction.

Verified insurance benefits, assessed financial responsibility, and assisted with equipment setup for patients being seen for MRI, CT, PET, and Ultrasound procedures. Conducted on the job training for new employees. Interfaced with management across departments to refine workflow processes and implement Lean workplace philosophy; presented Lean recommendations to senior leadership.