Cepheid

Leading the new generation of molecular diagnostic systems (40 billion US$ Market, +70K systems current install base, Operating in 180 countries, a Danaher Diagnostic Company)  "Over a decade ago, Cepheid set the standard for innovation in automated molecular diagnostics — and we’ve never looked back. Today, even with the largest installed base of any molecular platform, Cepheid is constantly innovating and evolving its capabilities. The GeneXpert® System has been heralded as game-changing by healthcare leaders across the globe — enabling institutions of any size, from small medical clinics to high-volume reference laboratories and hospitals, to access the speed and accuracy of molecular diagnostics. Cepheid’s growing Xpert® test menu spans multiple clinical applications including healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology" https://www.cepheid.com/en_US/about

Principal Program Manager, Molecular Diagnostics Systems 

Envista Holdings Corporation

•	Drive organization strategic direction by managing programs up to US$400MM in business revenue, 100 worldwide cross functional team members, in 192 countries & 7500 products (Danaher Spinoff Company). 

•	Responsible for a team of 4 direct reports (Build New Teams PMO & Engineering, Hire, Training, Mentor, Oversee, Evaluate), organization strategy, project funnel, resource allocation, and project prioritization. Managing and developing resources to deliver on New Product Development, Sustaining and regulatory objectives through phases and gates of the design control process.

•	Managing and accountable for product development, commercialization, technology transfer, and market expansion activities across organization departments, co-ops, and teams (R&D, Quality, Manufacturing, Marketing, Clinical, Regulatory and Supply Chain, and others). Establishing and maintaining team member and stakeholder relationships, expectations, and communication.

•	EU MDR MDD & Global Re-Registration: Responsible for strategy, priority, planning, coordination, resources, project/program management, budget objectives and reporting. Coordination of global muti-site cross-functional team responsible of the regulatory updates (Labels, Drawings, V&Vs, IFUs, Bio Compatibility), deployment (ECO/ECR/Variances), and transition of inventory (phase in/out) of new revisions. All with coordination of the respective audits for the technical files, including sales forecast and global in-countries bridges inventories.   

•	Mentorship (project / program / portfolio subject matter expert): Select, Hiring, Onboarding, and Mentor 100% of the PMO team (DBS, PSP, VPM, Visual Project Management, Lean, Shingijutsu, Kaizen, Workshops, Gemba). Develop talent development and succession planning. Hands on drive global cross functional teams (meetings, agenda, milestones, best practices, minutes, action items, critical path…)

Director R&D Project and Program Management (PMO)

Envista (NYSE: NVST, Mkt Cap US$ 7B) —KaVo Kerr, Nobel Biocare Systems, and Ormco—represent more than 125 years of dental industry excellence. These companies and the trusted brands comprising them were originally acquired as part of Danaher’s $2.8B Dental Platform, and now stand together to meet the end-to-end needs of dental professionals worldwide. ( https://www.envistaco.com/about )

Senior Manager, R&D Medical Devices - Project / Program Management

•	Portfolio Management: Prioritization of resources across multiple projects (scope, schedule, and cost). Evaluation of teams, projects, and programs for resources, budget (P&L, NPI, Forecast…), long term vision, direction, strategy, and their continuous improvement to meet company strategy and vision. Proper stakeholders’ communication (technical, business, executive).  

•	PMO Management: Within the Program Management Office (PMO) - Diagnostics Division (IVD, POC, Medical Devices and their consumables). Responsible for Lead, Director, Guide, Program / Project Management, Best Practices Development / Deployment, and Mentoring of Global Cross-Functional teams. Accountable for user inputs, tasks, strategies, schedules, budget, critical path, milestones, deliverables, risks and mitigation options.

•	Team Building and Mentorship: Mentor, build, train, and develop Global Cross-Functional teams. Develop a comprehensive e inclusive talent development and succession planning. Delivering cross functional programs teams with Core Team Leaders and cross functional engineers to support program portfolio objectives.

Senior Manager, Diagnostics R&D - Project / Program Management

Beckman Coulter

•	Within the Program Management Office (PMO) - Diagnostics Division (a Danaher company). Responsible to Build, Lead, Director, Guide, Project Management, and Mentoring Global Cross-Functional teams, to deliver +$1.5MM market new systems (NPIs, Hardware HW + Software SW) and support current products throughout their lifecycle (+10K IVD instruments worldwide). 

•	Proactively evaluation of teams, projects, and programs for resources, budget (P&L, AOP, Forecast…), long term vision, direction, and strategy for a +$100 MM program portfolio.

•	Work, resolve, implement teams and cross departments’ strategies. Delivering 4 cross functional programs teams with Core Team Leaders and over 20 cross functional engineers on average each to support +$100 MM portfolio programs.

•	Plan, Build, Source and Delivered (hardware and software) devices and infrastructures (+$4MM deployment) to support new regulations (FDA, HIPAA, GDPR) and future growth for US, EU, and China markets allowing +50% expansion of connected ecosystem instruments.

•	Select, Onboarding, and Mentor 50% of the PMO team. Hands on drive four global cross functional teams (meetings, agenda, milestones, best practices, minutes, action items, critical path…) including projects & programs stage gate approval process, executive updates, and requests for support (escalations). 100% delivering milestones on time and without compromising critical path to support company devices and ecosystem (HW+SW), by levering cross functional teams.

•	Develop and implementation of Cross Functional Agile Development Models (Hardware + Software), Risk Mitigation, Scrum Methodology, Continuous Integration (CI), Continuous Delivery (CD). Creating, updating, and releasing corporate global quality system procedures to support the new fast iterative and incremental R&D development process (Waterfall + Agile integration, Agile Project Management (APM)). Implementing first agile development system in company +80 years of history.

Senior Program Manager, Diagnostics R&D - Project / Program Management

Midmark Corporation

•	From Concept to Market (E2E): Functional, Technical, and Project / Program Leader bringing new diagnostic platforms (FDA Class 2, Released in 3yrs, including FDA 510K approval) +10MM/year initial market. 

•	Management: The scope of my activities reaches FDA 510K submissions and their direct hands on support, including (but not limited to) design control, design history file, requirements definition, research, development, verification, validation, schedules, milestones, budgets (NPI, AOP, Forecast, NPV analysis, P&L implementation, and cost improvement projects…), options & negotiation, stage gate meetings & approvals, vendors & contractors management, testing (internal external laboratories), quality assurance & regulatory compliance (FDA CFR 21 part 820, IEC 60601, ISO 13485…), risk analysis, risk management, reliability, key stakeholders interface (Executives, Product Managers, Customer Support, Service…), production lines (design, setup, automation, improvement, updating) and continuous improvement process initiatives (CIP, Kaizen, Lean Six Sigma Green Belt LSSGB).

•	Portfolio Management: Responsible for Source, Built, Lead, Mentor, Guide, and Program Project Management (PMO) of Global Cross-Functional teams for Research and Development (R&D). 

•	New Product Introductions and Sustaining Engineering: Accountable for new and existing products throughout their life cycle (Medical Devices FDA Class II), by the direction of subordinates (full time, contractors, and OEMs) and or from the front line (hands-on, mentoring).

Engineering Manager

Manage the New Product Development (NPD) projects from inception to release (Program Manager, Project Manager, PMO). Own the NPD development process and work with manufacturing, quality, and engineering to ensure that the process complies with the quality system and FDA regulations (Medical Devices, FDA Class II). Own and maintain the device’s master records. Create, setup, and update production lines, manufacturing processes, and test procedures. Lead risk analysis, Failure Mode and Effects Analysis (FMEA), Kaizen (Lean Six Sigma) and continuous improvement activities.

Project Engineer - New Product Introduction (NPI)

CareFusion (Formerly: CardinalHealth, Viasys Healthcare)

•	Management: Under the plant Director of Engineering (R&D), position for which I hold backup responsibilities for a FDA Class 2 and 3 Medical device plant of 350 employees, 15 lines, +$120MM/year sales. 

•	Continuous Improvement: Covering all critical care ventilation and diagnostics products (Medical Devices Diagnostic and Respiratory System, COPD Capnography, Flow and Cardio-Respiratory Sensors FDA CLASS 2 and 3. Responsible for +$100MM in Savings (CIP, Lean Six Sigma Green Belt - Certified). NPV analysis, P&L implementation, and cost of improvement projects.

•	Mentoring and Project/Program Management: I source, built, direct, lead, manage, program project management (PMO) and mentor multiple and parallel cross-functional teams for the Research and Development (R&D, EE, ME, Systems, SW, HW, V&V, Testing…), Sustaining, Product, and Manufacturing Groups.

Principal Engineer

Electrical Engineer (MSEE – MBA) part of the R&D, product sustaining / product engineering group, I support the medical devices systems (Critical Care – Life Support Systems) throughout their life cycle. This was accomplished by hand on research and application of electrical engineering theory and principles, decomposing requirements, establishing specification, component selection, PCB layout, testing plans / protocols (CE, EMI, EMC, Electrical Safety, IEC 60601-1 3rd edition, RoHS Compliance, FDA CLASS II, FDA CLASS III, ETL, IEC, UL, HALT, HASS…), verification and validation of the solution, to creative and efficiently support current and legacy products, including key obsolescent production issues. Direct and mentor cross functional junior and technical staff. Contribute to design reviews. Proactive identification, capture, documentation, verification and solutions release (ECO) for production issues.

Senior Electrical Engineer

Weil Institute of Critical Care Medicine

•	Biomedical system engineer leader
•	Program Management, Project Management (PMO)
•	Manager for multiple and parallel programs / projects / protocols of a multidisciplinary medical research teams, focus in cardiovascular, cardiopulmonary and brain resuscitation. 
•	Hands on:  voice of the customer (VOC), specification development, concepts/white page (patents), prototyping (Labview, AutoCAD, OrCAD, Pads, Solidworks, DataQ, biosensors / circuitry analog & digital +) and their production related processes. 
•	Hands on leadership for cross functional medical research, experiments (Bench, V&V, in vivo, in vitro, preclinical, stem cells & animals in catheterization laboratories / Cath Lab), preproduction units (PCBs, PCBAs, parts machining) and their tests (Proof of concept / FDA Class II & III). 
•	Proper publication (20+), in medical conferences and medical research journals.

Research Biomedical Engineer

EmhartGlass

Worldwide hands-on manager of R&D engineering programs/projects, research specialist in instrumentation and control devices, supporting the transition from design into a production.

R&D NPI Engineer

Salter Labs

Manager (Biomedical Project Engineer) for new product introduction plant (medical devices - clean room manufacturing).

Project Engineer Manager

Siemens Healthcare

Served as worldwide bioengineer life support specialist (Life Support & Intensive Care Systems, CPR & Medical Interventions, Electrophysiology, Catheterization Laboratory, cath labs, Ultrasound, Mechanical Ventilation, Critical Care Monitoring, Anesthesia Machine/Systems, Defibrillators, +...), providing research, project engineering, application engineering, sales support and management.

Biomedical Engineer

From Concept to Market. Providing hands-on expertise in global portfolio management, cross-functional project management, program management, product development, and engineering management. Consistently deliver integrated solutions that yield tangible bottom-line rewards and market impact. 

•	Expertise in MEDICAL DEVICES (FDA CLASS 2 & 3)
•	PhD Doctor of Management in Organizational Leadership (In progress) 
•	Masters in Business Administration (MBA), Finance (MSF), and Electrical Engineering (MSEE)
•	Lean Six Sigma Green Belt Certified (LSSGB)
•	Committed to Continuous Improvement Process (CIP) with +$100MM in Production Saving accomplished 
•	Leader that routinely managed +$100MM multiple global cross-functional projects (see my +70 recommendations)
•	Resourceful hands-on design and problem solver that provides unique solutions in many engineering disciplines
•	Skilled communicator, proficient in client presentations, and participation in marketing support activities
•	Team player that seek challenge and an opportunity to learn and growth
•	+25 Peer Reviewed Publications in Top Medical Journals.

WORK EXPERIENCE
Principal Program Manager  • www.cepheid.com
Director • www.Envista.com
Sr. Manager • www.Envista.com
Sr. Manager • www.BIT-Group.com
Sr. Manager • www.BeckmanCoulter.com
Engineering Manager • www.Midmark.com
NPI Project Engineer • www.Midmark.com 
Principal Engineer • www.Carefusion.com 

SPECIALTIES 
Medical Devices Research R&D, New Products Development / Introduction NPD NPI, 510K,  Diagnostics, Biomedical Eng, Project / Program Management, Critical Care, Predictive Analytics, SaaS

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