Daniel Schabacker Email & Phone Number

R&D Project Manager leading capital and consumable product development projects/workstreams related to medical device - reprocessing and terminal sterilization in order to protect patients during their most critical moments:• Leading the creation, implementation, reporting, and communication of project plans.• Ensuring plans and deliverables are compliant with appropriate ASP design control procedures. • Leading project teams and identifying and addressing critical path constraints… Show more R&D Project Manager leading capital and consumable product development projects/workstreams related to medical device - reprocessing and terminal sterilization in order to protect patients during their most critical moments:• Leading the creation, implementation, reporting, and communication of project plans.• Ensuring plans and deliverables are compliant with appropriate ASP design control procedures. • Leading project teams and identifying and addressing critical path constraints or road blocks • Developing, maintaining and using tools for organizational tracking such as budgets, resource deployment, project status/reporting, etc.• Serving as lead contact for all internal cross-functional stakeholders (manufacturing, accounting, purchasing, sterilization, packaging, etc.) regarding development and execution of project plans and project risk analysis for all projects project activities• Determining key project constraints such as scope, schedule, budget, resources and risks.• Communication of project status and project/product risks to all project stakeholders. • Typical communication includes: project meeting minutes, presentations to governance boards, post-introduction reports, development of project metric tools, and any status or project detail information needed.• Creation and approval of project budgets Show less

Greater San Diego Area

Stratus and Associates is a sole proprietorship. Through client agreement, Stratus is able to function as a project manager, study director, study monitor, or in a regulatory support role to address a full range of regulatory development project management/leadership services.Specific Product Development Services Include:• R&D and Regulatory Product Development Study Management and Monitoring built on principles of Project Management best practices; Creative Solutions to Test… Show more Stratus and Associates is a sole proprietorship. Through client agreement, Stratus is able to function as a project manager, study director, study monitor, or in a regulatory support role to address a full range of regulatory development project management/leadership services.Specific Product Development Services Include:• R&D and Regulatory Product Development Study Management and Monitoring built on principles of Project Management best practices; Creative Solutions to Test System Challenges. • Knowledgable in Design History File preparation, Quality Assurance, and GLP audit and inspection compliance (FDA, EPA, OECD) • Data compilation, management, reporting; Data interpretation, evaluation, and reporting Areas of expertise:• Enzyme (Microbial & Bioprocessed) and Agrochemical (Crop & Professional Products)• Practical understanding of Global Quality Assurance and Regulatory requirements and regulations as well as the importance of the regulatory view of risk assessment, product stewardship, and business issues affecting regulated products. Demonstration of professional, entrepreneurial approaches with a self-starting, self-motivated, passion for the product development work environment. Show less

Irvine, California, United States

Quality Engineering and Risk Management subject matter expert in the medical device and consumable technical field, exercising considerable latitude in determining technical objectives of assignments and project deliverables. Typical cross-functional interaction results in the development of new or refined methods to reduce/mitigate risk in equipment, materials, processes, products and or technical methods.Typical responsibilities include:• Review results of area audits to ensure that… Show more Quality Engineering and Risk Management subject matter expert in the medical device and consumable technical field, exercising considerable latitude in determining technical objectives of assignments and project deliverables. Typical cross-functional interaction results in the development of new or refined methods to reduce/mitigate risk in equipment, materials, processes, products and or technical methods.Typical responsibilities include:• Review results of area audits to ensure that corrective and preventive actions are adequate; partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges;• Support legacy medical device continuous product improvement projects through quality plans, review of design change plans, supplier change requests, design reviews, development of regulatory support documents (e.g., 510(k)), and review of technical reports, drawings, and other product and product risk documentation as required;• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs, and customer complaints; support of Product Quality and Risk Management activities during authority on-site inspections; • Develop and manage the ASP risk management process and work instructions per ISO 14971 that establish and maintains quality system policies, processes, procedures and controls to ensure that the performance and quality of products conform to established standards and agency guidelines.• Risk-focus: Participated in the revision or development of methods or procedures to ensure consistent remediation of legacy products and utility in the New Product Development processes. Fully remediated via protocol and controlled documentation, five legacy product risk management files. Show less

Santa Ana, California, United States

Led global ophthalmic medical device development projects according to PMI PMBOK best practices, applicable standards and regulations with emphasis on risk mitigation, global regulations, and guidance. Familiar, for example, with FDA 21CFRPart 820, ISO Standards, EU Medical Device Directive, GMP / GCP / GLP, and US and EU Pharmacopeias.Managed OVD (Ophthalmic Viscosurgical Device), IOL (Intraocular Lens - cataract eye surgery medical device), Over the Counter (OTC) Eye Care Solutions… Show more Led global ophthalmic medical device development projects according to PMI PMBOK best practices, applicable standards and regulations with emphasis on risk mitigation, global regulations, and guidance. Familiar, for example, with FDA 21CFRPart 820, ISO Standards, EU Medical Device Directive, GMP / GCP / GLP, and US and EU Pharmacopeias.Managed OVD (Ophthalmic Viscosurgical Device), IOL (Intraocular Lens - cataract eye surgery medical device), Over the Counter (OTC) Eye Care Solutions, Software Validation, and IOL Power Calculation Projects through:• Emphasis of the critical utility of product life-cycle stage gate and design control processes culminating in completion of design history files, functional submission to / approval by authorities, product manufacture, and launch / post-launch.Supported development of and piloted the New Product Development Process (NPDP), systems, and tools through:• Practical management of the process, development and led cross-functional global teams, developed strategic approaches to the projects, driving execution, and intimately developing the regulatory dossier components associated with the business, clinical, engineering, manufacturing, operations, quality, regulatory, R&D, and supply chain. Developed and managed the Design History Files (DHF).Managed software validation life-cycle projects through direct development of documentation, execution of qualification testing, and management of overall delivery of product.Accountable for overall and consistent project management and processes: scheduling; determination of and negotiation for functional resources; budget / forecast management; risk and issue management; technical and cross-product / project knowledge; alignment with product development, stage gate, DHF, and design control processes during project execution. Primary contact point for project communication and metrics through all levels of management and staff. Show less

Project Management and Planning responsibilities supporting full breadth of Biotech Enzyme Division located in Raleigh, NC and San Diego, CA. Sector delivers products to the key biotech enzyme market segments: animal feed, biofuels and new output traits in agriculture. Portfolio included 15+ projects in various stages of life-cycle. Further, responsible for coordinating New Idea Management process within the Research and Commercial departments.

Based in Basel, Switzerland and Greensboro, North Carolina, position involved Project/Portfolio Management and Planning responsibilities of full breadth of sector portfolios with projects in various stages of life-cycle.Portfolio ran the spectrum of Research, Development, Commercial and Life-cycle Management product phases. Responsible for coordinating New Idea Management process within the research and commercial departments. Supervisory / management responsibility for… Show more Based in Basel, Switzerland and Greensboro, North Carolina, position involved Project/Portfolio Management and Planning responsibilities of full breadth of sector portfolios with projects in various stages of life-cycle.Portfolio ran the spectrum of Research, Development, Commercial and Life-cycle Management product phases. Responsible for coordinating New Idea Management process within the research and commercial departments. Supervisory / management responsibility for emerging Project Management Office in Greensboro Show less

Responsible for performing environmental fate studies at the laboratory level under Good Laboratory Practice Standards. Included method development and validation.

Reviewed federal and state action items on individual studies, prepared defences to agency questions and followed through with contracting new studies or upgraded work.Conducted on site GLP/GMP inspections, performed GLP/GMP data audits and prepared all necessary reports. Contracted and monitored regulatory studies at various laboratories, reviewed and edited protocols and final reports, and interacted with client company employees to assure scientific requirements were met as… Show more Reviewed federal and state action items on individual studies, prepared defences to agency questions and followed through with contracting new studies or upgraded work.Conducted on site GLP/GMP inspections, performed GLP/GMP data audits and prepared all necessary reports. Contracted and monitored regulatory studies at various laboratories, reviewed and edited protocols and final reports, and interacted with client company employees to assure scientific requirements were met as well as all project team submission deadlines. Show less

• Responsible for performing Environmental Fate studies at the laboratory level under Good Laboratory Practice Standards. Included method development and validation

Laboratory procedures and testing performed following acquisition of tissue/cells included the isolation and characterization of lipids, leukocytes, proteins and blood factors. Records were maintained involving the correlation, data analysis and graphic representations.

Master Science - Chemistry, Organic Chemistry, Pesticide Worker Exposure

Bachelor In Science, Chemistry, Math, And Geology

Education record