Paul Ginzburg

🔒 Efficiency Unlocked 🔒 - Formula Costing - Formulation - Label Creation - At Sleek Flow Labs, we believe in doing more with less. Seamlessly enhance your workflow, streamline processes, and eliminate inefficiencies. We architect sleek operations allowing your business to flow effortlessly.

Constructed an idea into a company. Versatile co-founder with the knowledge, skills, and experience to build a company. Raised funds, built a manufacturing facility, hired a team, and commercialized an innovative product.

Responsible for the strategic direction within the Sport Medicine business unit, including both internal research and development, as well as external business development opportunities.

Responsible for Operations and Business Development for a medical device startup that launched a novel spinal navigation platform utilizing custom 3D printed, patient specific drill guides. Drove verification and validation testing activities to obtain a FDA 510K clearance. Developed a limited market release plan and on-boarded a team of operations engineers and sales representatives. Established a product pricing strategy and aided in hospital contract negotiations. Implemented Key Performance Indicators for the business to drive an improvement in product quality, reduce product lead time, and increase the company’s bottom-line.

Responsible for the manufacturing floor, product quality, and plant compliance at Stryker Endoscopy. Leading a team of Process Quality Engineers and creating a top workplace culture. Stryker was recognized for Fortune’s “Best Companies to Work for” and was named three years in a row “Best Top Workplaces” by the Bay Area News. The Process Quality Engineering Group focuses on eliminated process variation through automation, mistake proofing, and implementing statistical process controls. Was able to improve internal and field quality, as well as, ensure product availability.

High focus on pre-launch design for manufacturability and process validation for Stryker Endoscopy. Participated in 4 product launches, focusing on printed circuit board assemblies (PCBAs), machining, injection molding, sheet metal fabrication, and box build assembly processes. Expertise in medical device manufacturing.

Experienced with regulated medical devices industry: Quality Management System (QMS), Design History File (DHF), Risk Analysis (DMFEA & PFMEA), Project Management (PM), Root Cause Analysis. • Experienced with ISO 8600-1 environmental requirements of medical devices and IEC 60601 electrical safety standards. • Experienced with SolidWorks, LabVIEW, MS Project, MS Office, 3D Printing, Laser Cutting, Laser Etching. • Complete several product launches. Skills: • Competent problem-solver with exceptional commitment to quality, communication, negotiation, and persuasion skills. • Managed and mentored small teams of engineers. • CAD: Solid Works, Master CAD/CAM • Over 5 years experience in medical device industry. • Strong Project Management background. • Familiar with GD&T and ASME drawing standards. • Design for Lean and Design for Six Sigma (DFSS) methodologies. • Design for manufacturing and Assembly (DFMA) • Design for manufacturability (DFM) • Rapid Prototyping. • Medical Device experience: FDA submissions, 510k, GMP / GDP, CAPA, 21 CFR part 11, IEC-60601, ISO 13485, ISO-14971, ISO 8600, ISO 9001, ISO 10993. Certified in ISO 10993-1. • Design of experiment (DOE), Writing test protocols and reports, Failure / Feasibility analysis, formal design process, risk management, FMEA, DFMEA, biocompatibility, verification and validation, reliability and efficacy testing. • Certified in root cause analysis. • Knowledge of clinical and regulatory pathways as well as IP (Intellectual Property). • Microsoft Office (MS Excel, MS Word, MS Access, MS Project), Matlab, Adobe Photoshop, Adobe Premier.

Marketing Technologies represents a conglomerate of industry leading custom plastic, metal, and printed circuit board assembly manufacturers. We take the time upfront to review and audit manufacturers across the United States before bringing them onto our team, so that we can confidently offer you the best US based supply chain. We are a solutions provider and eliminate problematic manufacturing through timely delivery and unmatched quality systems.