CONSULTING SERVICESBusiness Process Improvement:Streamline, define, and improve functional work. Create MS Teams and SharePoint sites to publish all information to support group members' work. Establish templates and guidance for all work, including project schedules, deliverables, and operational work. Project Management (PM):Lead & manage new product development projects. Establish PM processes and deliverables, train team members and management for business improvement, PM certification (PMP) prep, product development leadership and management, functional excellence. Expertise with Smartsheet for project schedules and spreadsheet, including forms, automated workflows, reports, and dashboards.Product Development:Establish/improve cross-functional product development process (PDP) & functional procedures, develop functional excellence & business process maturity, team member & management training, write or improve deliverables SOPs and templates. Business Partnerships / Alliances:External business relationship management, acquisition or merger due diligence and integration, co-development, venture capital investment milestones and project management, service contracting management (design/development, manufacturing, distribution agreements)Project Portfolio Management:Establish / improve strategic planning and project portfolio management practices, provide management services, train business planning and management personnel.PRODUCT TYPES- Medical devices: Class I, II, III, cardiovascular, orthopedic, ocular, minimally invasive, and other surgical tools and implants, combination products: pre-filled syringe, auto-injector, on-body drug delivery system, intravesical drug delivery device. Vaccines & mAb (including Covid), large molecule, small moleculeCLIENTS AstraZeneca (current, through Centofanti Consulting Inc), DePuy Synthes (J&J), Natus, Allergan, Terumo, MedImmune, Cirtec

Drove improvements in project leadership and project management practices.Leader of cross-functional product development project teams for new medical device development. Responsible for establishing project strategies and plans including project scope, schedule, budget, and resource plans, execution of plans on time and on budget, reporting to senior management on project status and decisions. Provide input to system and process improvements for medical device product development and project leadership and management best practices.• Led and managed cross-functional teams using stage gate process for new product development, from market research and initial concept to design & development, clinical trials and regulatory approval, into commercialization• Established project plans to meet aggressive timelines & drive efficient execution of plans• Tracked project progress (scope, budget, schedule, team performance) and presented to company leadership team• Established proposals for new projects• Identified and executed improvements to the Product Development Process (PDP) and design control procedures • Managed creation of the Design History File, including updates to historical records to meet current requirements• Managed contract design vendor and consultant selection, including legal agreement development • Involved in site closure and transition planningConsultant in product development and project management for additional 2 years after site closure layoff (see above experience at MedDev Consulting LLC)Product Types:Tissue expander for breast reconstruction, breast implants, combination drug delivery devices: pre-filled auto-injector syringe + drug; intravesical drug delivery device*Continued working with Allergan as a consultant after the Santa Barbara facility was closed.

Managed new product development program for cancer detection systems consisting of multiple in vitro diagnostic instrument (hardware, firmware, and software) and assay projects. Contribute to product development and project management system and process improvements to drive project team efficiency and success.• Managed program coordination across multiple project teams, including instrument and assay development for program with over $100 million budget• Established and presented project plans, schedules, and status updates to meet aggressive timelines• Ensured creation of design history file documentation per FDA and ISO design control requirements• Drove efficient execution of project plans, tracked and reported program progress• Identified and executed improvements to the Product Development Process (PDP), including training

Medical device and biotech industry consulting. See details in MedDev Consulting LLC above.

Director of R&D engineering and sustaining engineering groups for new product development and manufacturing support of cardiovascular medical devices. Chair of strategic planning and portfolio management team.• Managed direct and indirect reports – R&D Managers, engineers, and technicians• Hired, trained, and developed staff members – grew staff from 6 to 17 people in 2 years• Provided leadership and guidance for product development teams through technical challenges into commercialization• Participated in acquisition due diligence and integration• Supported clinical trials, regulatory submissions • Led development of a management team business process for strategic planning, project portfolio, and active project oversight• Guided development of project managers and improvement of stage gate product development process to meet regulatory design control requirements• Member of CAPA review board, complaints review board, invention/patent review board, management review • Products: guide wires, introducer catheters, occlusion balloons, Angioseal vascular closure product line, alternate vascular closure concepts (including large bore), collagen material development, sensor guided imaging

Manage supervisors, business process, and performance in the areas of Receiving Inspection, Supplier Quality, Complaints Investigation, Metrology/Calibrations, and Quality Engineering for Product Development. Manage total staff of 22+ employees.• Directed the following departments:o Quality Engineeringo Complaint Investigationo Receiving Inspection o Supplier Quality managemento Calibrations/Metrology o IOL Delivery System Mfr Process Development• Participated in Management Review meetings• Sustaining Engineering oversight• Quality/Regulatory audits • Organizational process improvements• Project management • Departmental budgeting• Reviewed and approved document change orders• Liaison for multi-site product development• Managed direct and indirect reports – including managers, engineers, technicians, & administration• Hired, trained, and developed staff members• Products : Implantable Intraocular Lenses (IOLs) and Delivery Systems

Led cross functional teams to develop cardiovascular medical device products from concept through post launch vigilance. Led corporate wide teams to develop business processes and improve quality in product development, CAPA, distribution, product control, alliance/partnership management, business development.

Led cardiovascular medical device product development teams, lead design engineer, responsible for all aspects of product design from concept and technology research through design verification and validation.

Developed R&D and pilot production level manufacturing processes for new cardiovasular products. Worked with nickel-titanium (NiTiNOL - a shape memory alloy) to develop metal treatment processes for laser cutting, surface finish, metal state temperature treatment for shaping, finishing, loading into delivery devices, etc. Responsible for developing test methods and test plans for performance of quality control and design and process validations, carrying out testing, analyzing data, writing validation reports, presenting findings and making design and process change recommendations.

A battery R&D and Manufacturing company. Responsibilities included developing a data collection and analysis system for R&D product development, manufacturing equipment development, manufacturing process development, industrial engineering, pilot production supervision and training, testing oversight.

Performed research in the areas of chemistry (ultra-high vacuum chamber), biochemistry (platelet activation), and nuclear waste research in the following institutions:Centre l’Energie Atomique (CEA)Bagnols Sur Ceze, France. -A French National Laboratory.Kernforschungzentrum, Karlsruhe (KfK), Karlsruhe, Germany. -A German National Laboratory.University of Wisconsin-River Falls-Chemistry DepartmentUnivesity of Minnesota, Minneapolis, MN - School of Medicine

Teaching Assistant and Tutor for undergraduate chemistry and physics, Graduate Teaching Assistant/Instructor for undergraduate engineering courses- 'Radiation Detection and Measurement', and : ‘Data Analysis and Experimental Methods’. Teaching Experience included the following schools:University of Arizona Tucson, AZ -Nuclear Engineering DepartmentUniversity of Wisconsin-River Falls-Chemistry and Physics DepartmentsNorth Hennepin Community CollegeBrooklyn Park, MN- Chemistry Dept