Oversight of development and advancement of the Company’s Selective Cytopheretic Device (SCD), a patented cell-directed extracorporeal therapy that works with continuous kidney replacement therapy (CKRT) systems to selectively target and reduce the inflammatory effects of activated neutrophils while transitioning pro-inflammatory monocytes to promote reparative processes. The pediatric SCD (SCD-PED) has been granted a Humanitarian Device Exemption (HDE) by the FDA for use in children >10 kgs with acute kidney injury (AKI). Commercial launch of SCD-PED is occurring in the second quarter of 2024.

Management of product development and manufacturing between client, contract manufacturing organization, and RA/QA, ensuring business objectives and agency regulations are met. Facilitate FDA product submissions, responses to agency questions and compliance audits. Oversight of contract manufacturing activities, execution of process qualifications, and remediation of compliance documentation.

Engineering, operations, and project management for small to large companies, from start-ups to established firms. Expertise in business systems and strategies, manufacturing operations, engineering and project management, sales management, new product development and introduction, product and process development, budgeting, and fiscal management.

Compliance documentation for product development and design control. Collaborated with external stakeholders and agencies to conduct internal and external audits. Designed process and equipment validations, and packaging design and validation. Remediation of design history files for liposuction and nasal technologies.

Bovine Tissue Heart Patch:Project management and technical support for manufacture of implantable, bovine pericardial tissue heart patch (trade name PhotoFix™) with primary application in pediatrics for congenital heart defects. Direction of internal/external engineering resources. Identification and integration of outside consultants. Process qualifications (IQ, OQ, PQs) and validations (V&V). Application of photooxidation chemistry and processes. Laboratory sourcing/interface for autoclave sterilization and validation, bioburden, pyrogenicity, and cytotoxicity testing. Ethylene oxide (ETO) sterilization qualification. Aseptic processing and media-fill qualifications. Development of packaging and labeling. Problem investigations and resolutions. Write segments of EDQM and CE registration submissions. Compliance with FDA GMPs, 21 CFR Part 820 requirements, and ISO/ANSI/AAMI standards.Annuloplasty Rings and Bands:Program/project management and technical support for development of implantable annuloplasty rings and bands for heart valve repair (trade name FlexForm™). Direction of engineering resources. Development of manufacturing procedures and process validations. Wrote segments of FDA 510(k) submission for performance, biocompatibility, sterilization, and MRI compatibility. Compliance with FDA GMPs, 21 CFR Part 820 requirements, and ISO/ANSI/AAMI standards.

Manufacturer and distributor of drug infusion pumps and related disposables. Operational leadership of manufacturing, engineering, purchasing, inventory control, shipping, receiving, facilities, and service. Facilitated acquisition, validation, documentation, and design transfer of drug infusion pump from Israel to the U.S. Conducted due-diligence for acquisition, hired and trained staff, developed operating plans and budgets, negotiated contracts, and implemented cost-reduction methodologies for product transfer and scale-up.

Contract manufacturer of Class II and Class III Medical Devices. Analyzed and remediated engineering and manufacturing processes, ensuring accountability and clearance of pre-existing FDA Form 483 observations. Managed programs, implementing and documenting procedural changes where needed. Oversaw V&V and internal audits and liaised with clients to address business and customer needs.

Manufacturer and distributor of autologous blood salvage equipment and disposables. Led cross-functional teams for design and manufacturing of medical devices, including new acquisitions from Europe. Project management and execution for transfer of manufacturing and engineering operations from Colorado to Mexico. Implemented manufacturing processes, investigated field failures, and spearheaded task forces to remedy design flaws.

Oversight of five sales territories in thirteen states with responsibility for increased sales and profitability. Successful turnaround of the poorest performing district to become the number one sales district in the nation within a 3-year period. Established and executed pricing and sales strategies to increase sales and exceed profitability targets. Hired, trained, and developed outside sales representatives. Handled at-risk accounts and contracts to re-establish company credibility. Collaborated with hospital executives to revitalize underperforming areas.

Management of a $50M product line operating three shifts at two facilities with 300 employees. Planning, staffing, training, budgeting, cost reductions, regulatory compliance, employee safety, personnel relations, and operational issues resulting in a 400% manufacturing scale-up, increased product reliability, and reduced customer complaints.

Manufacturing engineering, process development, V&V activities, quality and yield improvement, regulatory compliance, and technical documentation. Reduction of cycle times by eight days, floor space by 75%, and product defects by 10% through implementation of LEAN manufacturing principles.