Meet Andy

Position Summary:  Mr. Schimmoeller served as technical lead engineer for both electrical and cross-functional teams for multiple projects. Some of Mr. Schimmoeller’s design efforts include the following: electronics miniaturization, low power devices, wireless sensing technology, radioisotope dosimetry sensor technology, drug delivery devices, neuro technology, and In Vitro Diagnostic (IVD) devices and analyzer systems. Mr. Schimmoeller developed expertise in electrical architecture and design, systems engineering, product safety and EMC compliance, verification protocol development and testing, and project and task management.

Body-Worn Sensor Mr. Schimmoeller was responsible for leading the usability engineering risk analysis, safety risk analysis, development of product requirements, and safety compliance planning. He was also assisted the client with a developing a platform-based architecture approach for design input documentation.

Wireless Body Fluid Sensor Mr. Schimmoeller was responsible for project management over six development partners for a startup company. He was also responsible for compliance engineering to the appropriate safety standards and usability risks assessments in alignment with the FDA expectations.

Cardiac Image Processing Software (SaMD) Mr. Schimmoeller was responsible for managing in the project and ensuring compliance with client SOPs. Additionally, he reviewed subcontractor documentation to ensure that met the needs of the project and the client’s expectations.

Quality System Implementation Mr. Schimmoeller served as project manager for the creation and implementation of a Quality Management System.

Traumatic Brain Injury Prevention Device Mr. Schimmoeller was the project manager and lead verification activities for an updated design. He coordinated with 3^rd party vendors for device testing and biocompatibility assessments.

Blood Analyzer Mr. Schimmoeller led the electrical engineering and architecture on a laboratory blood analyzer. He was also responsible for ensuring design compliance with safety standards for in vitro diagnostic equipment.

Connected Autoinjector Mr. Schimmoeller was responsible for electronics functional verification including the development of the verification plan, verification protocols, identification and validation of support tools, verification procedure execution, issue tracking and resolution, and delivery of verification test results. Additionally, he supported the development of product requirements and identification of applicable clauses of IEC 60601 and strategy for IEC 60601-1-2.

Disposable/Reusable Autoinjector Mr. Schimmoeller was responsible for the electrical concept development of various hand-held and wearable autoinjector drug delivery devices. Key efforts included identification and integration of applicable sensing technologies, power management, connected platform development, and mapping device functionality to reduce anxiety in the user/patient experience.

Transcranial Doppler (TCD) Portable System Mr. Schimmoeller led a >$5MM electrical engineering effort to design a battery operation TCD system used for traumatic brain injury assessment in a military medical environment. The system implements ultrasound, high speed processing and memory, power management, and robotic motor control.

Radionuclide Infusion Device Mr. Schimmoeller led a cross-functional multi-company feasibility and design implementation team for detectors measuring both the static and dynamic flow measurements of a radioactive eluate. Additionally, he oversaw the development of the electrical system components. Mr. Schimmoeller also led the effort for certification of the product to IEC60601 for safety and EMC compliance to IEC 60601-1-2.

NeuroLife^® Mr. Schimmoeller was responsible for the initial transition from pure research to a deployable platform a system that converts measured brainwave activity and correspondingly stimulates nerves of the hand and arm of a paralyzed limb to generate functional motion. Additionally, he oversaw the development of an electromyography (EMG) system intended as a stand-alone and integrated product. Mr. Schimmoeller was responsible for the technical oversight as well as the electrical design safety and EMC compliance for systems.

Dry Powder Inhalation Device Mr. Schimmoeller worked on the electrical circuit board design in the evaluation of components, schematic and layout review, and troubleshooting of an ESD issue. He was also responsible for the design of Bluetooth Low Energy electronics and antenna into the design.

Insulin Pen Electronics Integration Brainstorm Mr. Schimmoeller managed a brainstorming effort for concept generation in a handheld drug delivery device to add sensor-based feedback, integration of a power source, and incorporated a ‘wireless connected’ functionality for data collection and patient compliance.

Premature Infant Inhalation Device Mr. Schimmoeller was the Electrical task lead and Safety and Compliance Engineer of a clinical aerosolization device that delivered drug to premature infants. His responsibilities included architecture development and oversight of power system, wiring system, electronic circuit board development, system component selection, evaluation of safety and EMC compliance, and verification of electrical system performance.

Continuous Glucose Monitor – Cogent Electrical and Compliance task lead, electronics design, embedded design, optical LED drive and photodetector, wireless communication, battery operated, clinical device, EMC and safety compliance planning and testing, system architecture development

Radiopharmaceutical Injector for Imaging Manage project for feasibility of radioactive isotope dosimetry sensor using CZT crystal. Circuit simulation for charge amplifier, Gaussian pulse shaping, and baseline restoring circuit.

Low Power Microwave Sensor for Detection of Subcutaneous Changes in Human Tissue Sustaining Engineering Effectively manage project for continued engineering support and documentation transition to client. Manage component obsolescence, direct hardware and software verification, respond to field issues inclusive of radioactive isotope testing.

REBS Directed electronics tasks and designed key subsystems and system architecture on a spectroscopic based biological detection system. Sensors, motors, fluidics were interfaced with a combination of custom and commercial hardware.

Personal Health Monitor Station Lead electrical engineer for safety analysis for compliance to IEC 60601. Performed product deconstruction and evaluation generating a GAP analysis and recommendations for compliance to applicable medical safety standard.

Ventilator EMC Investigation EMC trouble shooting and design change evaluation for mature product for initial launch in Japanese market. Researched applicable standards and coordinated testing on EMI suppression solution.

Infusion Pump Corrective and Preventative Action (CAPA) Investigation Project manager for multiple tasks addressing hardware and software investigations. Task lead and chief engineer for battery lifecycle evaluation.

Low Power Microwave Sensor for Detection of Subcutaneous Changes in Human Tissue. Mr. Schimmoeller served as the task lead for several subsystems. In addition to monitoring progress and budget for his tasks, he also wrote design specifications and testing procedures. Mr. Schimmoeller was responsible for the design and testing of circuit boards for power, system controller, user interface, and data transmission.

Tissue Impedance Measurement Device. Mr. Schimmoeller was the lead electrical engineer in the rapid development of a system to measure impedances in selected areas of the human body. This battery-powered product was developed and ready for demonstration at a tradeshow in 3 months from the start of the project. His responsibilities included prototyping, designing, and testing the electronics as well as the complete system. The design included a high-speed opto-isolated communications path with a PC, controlled current and controlled voltage drive and monitoring circuits, and multiplexing a large sensor array.

Respiratory Inhalation Device. Mr. Schimmoeller worked on-site as electrical engineering support on a design for large-scale manufacturing. The design is battery operated and includes an LCD, DC High Voltage, Breath Actuation sensing circuit, low voltage motor drive, current and voltage feedback, and position sensing for a small volume pump. The medical device is UL2601 compliant. Responsibilities included circuit board design, prototype PCB layout, fabrication, functional testing, debug, and documentation. Additional responsibilities included relationship management and quality system control for the electrical design.

Electrosurgical RF Ablation Device. As a member of the team, Mr. Schimmoeller was involved in the client’s Quality Function Deployment (QFD) process. Mr. Schimmoeller was also part of the proposal team and initiated a proposal for modeling RF effect on tissue. As a design team member his responsibilities included the design, layout, and evaluation of prototype analog circuit boards.

Electric Field Effect Technology (Drug Delivery Device). Mr. Schimmoeller was the lead electrical engineer for the development of the system platform technology and two battery operated clinical device designs. He was responsible for design, fabrication, and testing for several iterations of prototype and clinical printed circuit assemblies. The product design won an R&D 100 award in 2003. Additional responsibilities included user interface hardware and writing and testing electrical hardware specifications for the design. The design was required to meet UL2601 specifications, including EMC compliance.

Slide Imaging System. As a team member of this large design effort on a slide imaging system, Mr. Schimmoeller was responsible for the power distribution subsystem for both the Imaging System and the Image Process Controller. Included in this are power supply selection, fusing, and cable and wire harness designs for prototype and pilot builds. Mr. Schimmoeller designed the product for UL3101 compliance and was involved in EMC testing. He played a significant role in troubleshooting and electronics support for developmental hardware.

Patent Review (Due Diligence). Mr. Schimmoeller performed an intensive on-site patent due diligence project in cooperation with the client personnel resulting in the successful acquisition of an electrosurgical device. Over 3000 patents were reviewed in a one-month period, with technical analysis and experimentation performed.