Social media emphasizing empathy, healthy relationships, social benefit and emotional intelligence. Play nice.

For assistive and rehabilitative medical device startups, shepherd a specific company focused on reducing hand tremors through customer interviews and business model development, translating insights into operational plans and helping to execute those plans. Assist cohort of 6-12 companies in overarching goals such as education while providing strategic feedback during group sessions.

Provide strategic and tactical business advice to a stream of small life science companies in support of regional economic development goals. First mentored company focuses on delivery of services to domestic violence victims using a clandestine cell-phone app to avoid detection by abuser during service delivery.

• Congenica - Guided technical and regulatory strategy for rare disease genetic diagnostic, including machine learning component while writing FDA presubmission in anticipation of initial FDA clearance.• MindTrace - Led technical strategy development for initial FDA presubmission filing for advanced machine learning based neurosurgery outcome prediction in anticipation of subsequent FDA breakthrough designation filing and provided guidance to quality management system implementation.• OptoCeutics - Led proposal writing for NIH NIA Fast-track SBIR, business plan for EU grant proposal, literature review and CER for Alzheimer's therapy with neurocognitive, fMRI and MEG metrics.• Carestream - In-depth technical literature reviews of state of the art of clinical research in Cone Beam Computed Tomography (CBCT), Computed Radiography (CR) and Digital Radiography (DR) imaging.• ECMedical - Developed commercialization strategy for government proposal for first use of artificial organ technology, including business model, go-to-market plan and staffing plan.

Provide business advice to small company startup MRIMath for neuro-radiology tumor segmentation artificial intelligence product development.

Philips Respironics• Led comprehensive EU MDR gap assessment and gap remediation “ready for audit” planning and execution for multi-national MDSAP-compliant organization, including internal audit, to achieve EU MDR compliance.• Structured, managed and led EU MDR gap assessment across all relevant functions. Oversaw immediate remediations and verified them via internal audit. Planned remediations for external audit readiness. • Authored new processes and process modifications for clinical, marketing and audit.• Mapped new MDR requirements to MDSAP internal audit checklist.Bausch + LombEvaluated integration standards technology and competitive landscape and implemented risk reducing software demonstration, resulting in detailed plan for actionable path forward.

• Matured concussion, eye tracking & virtual reality medical devices, including engineering, quality, regulatory, risk assessment, production, field service, and project management in dynamic small company.• Motivated production staff using new behavior based performance management framework.• Managed supply chain for complex electromechanical medical device in austere financial environment.• Product development strategy and execution combined technical capabilities; marketing opportunities; financial, quality and regulatory constraints; and user priorities.• FDA-facing quality and regulatory lead included planning for international expansion. Led and received regular 510(k) (K171884) for new virtual reality product platform plus related FDA pre-submission and special 510(k).• Coordinated company activities; included company strategy, coordination of product development team - professionals in regulatory, preclinical and clinical development, scientific and medical writing, project management, business law, and patent law.

• Led software selling, engineering, project management, process improvement and security efforts.• Captured and led $300K ONR visual saliency algorithm development effort for UAVs, including developing C software version of MATLAB saliency algorithm for embedded system. • Developed EEG concept to evaluate collaborative software design alternatives. • Led demonstration of mission command metrics showing unit effectiveness from combat data. • Developed approach for >10% process-related savings for large software effort.

• Developed business for advanced concepts and led resulting efforts, grew sole source government contracting and led resulting efforts. Gained new facility clearance as FSO, managed engineering and deployment and realized supplier savings to enhance profit margins. • Scaled protein production to 1000 liter yeast fermentation and kg quantity in mushroom, resulting in 5x cost reduction for most costly raw material and corresponding 2x increase in margin.• Captured contract and led team to develop next-generation biofuel technology, including transcriptomics, bioinformatic analysis, and expression of newly discovered full-length genes.• Increased IDIQ contract from $20M for 5 years to $40M for 6 years, including core tech development, sensor development and operational test exercises. Led select associated task orders day-to-day.• Implemented “from scratch” facility security clearance plus 3 yrs as Facility Security Officer. Established foundation for performance of ~$12M in classified contracts.• Led systems engineering for JFPASS, a fielded US Army force protection system of systems including C2, COP, sensors, video, access control, robots and weapons; used DoDAF views.• Oversaw mobile video surveillance system training for Qatar product install, with one assistant. Developed training materials & delivered English training in person, translated to Arabic.

Founding CEO of start-up fabless semiconductor company focused on hardware implementation of visual algorithms, built from scratch to ~$1M in annual revenue in 3 yrs, part time. Managed 8 and led operations, business and tech development, admin, legal, financial, and project management.• Performed administrative and legal activities to incorporate and do business in 6 states.• Won 2 DARPA subcontracts, totaling ~$6M, to develop technology without equity dilution.

Grew from initial role as fingerprint algorithm development software engineer to lead systems engineering of multiple complex systems. Led both a $70M proposal and, as a Six Sigma Black Belt, process improvement initiatives that saved >$6M; successfully recruited from strategic academic talent pool; and led core technology development and for counter-terror program that exceeded <1/250,000 false alarm goal and booked multiple $B in company revenue.• As 6 Sigma Black Belt, managed production and logistics streamlining, booked >$6M savings.• Led $850K R&D, including GIS software, weapons, 3-d video, sensors and system M&S. Developed biological agent detector, including subcontractor management. Intelligent Munitions System weapon system C2 design during competitive phase of program. Safety requirement of <106.• As Bio-IPT Lead for USPS Biohazard Detection System, led multi-company team to mature core PCR sensor for anthrax in the postal environment until first article.• Chaired API standards consortium and executed optical fingerprint algorithm & middleware SW development.