Medical Device, MEMS, and Semiconductor ConsultantCross-functional R&D and operations experience in implantable medical materials, MEMS, other "thin film" devices, and semiconductors. My experience includes:- Blue sky market investigation and prototyping- Basic corporate research- Initial customer contact ,"white board" concept design, and quotation support- Design controls and DFM- Process development- Pilot line setup- Equipment PM and Calibration- Production ramp and transfer- Quality System Management and Yield improvement- Product/Process transfer, including OUS- Post market / field failure troubleshootingMicrochip and commercial MEMS experience:- Standard IC's (CMOS and BiCMOS)- Resonators- Accelerometers- Print heads- Various non-medical sensorsMEMS medical device experience: - Medical sensors (implantable and external)- Micropumps- Lab on chip solutions- MEMS-like processing with neurostimulation devicesMedical Device Experience:- Design controls- Standards compliance- Equipment and process validations (IQ, OQ, PQ, PPQ)- Equipment PM and Calibration- Verification testing- TMV- NCMR management- CAPA management- Auditing and FDA responseFormal training:- Lean Manufacturing: TPM, TOC- Six Sigma Green Belt Certification- Ford 8D- Statistics: DOE, SPC, passive data collection, Minitab, Jump, RS/1- Project management- LeadershipI have worked on NPD/NPI from Blue Sky to Launch. This includes blending design elements like scaling "thin film" solutions into traditional electromechanical spaces. As evidence of this, I haven’t just ideated many of the concepts in my patents, I have proved the concepts out, including fabrication and testing:- Implantable Thin Film Devices - US 10207103 B2- Implantable Devices with Thin Film Feedthroughs - US 10207199 B2- Systems and methods to reduce RF-induced heating of an implanted lead - US 20220143411 A1 (application)- Systems and methods for an antenna of an implantable electronics device - US 10587038 B2- Methods of manufacturing an antenna for an implantable electronic device and related implantable electronic device - US 10587038 B2- Medical Leads with Segmented Electrodes and Methods of Fabrication Thereof - US 9370653 B3- Medical Leads with Segmented Electrodes and Methods of Fabrication Thereof - US 10226619 B2