• EU-MDR program manager for several companies to include a medical technology company that develops and manufactures engineered collagen-based product lines for advanced wound care and tissue-engineered wound dressings overlay grafts for restoration and repair of dura mater.• Provided program management and subject matter expert services specific to the full adoption of all applicable harmonized standards to obtain an EU Medical Device Regulation 2017/745 Quality Management System (QMS) certification. • Within 6 months provided the executive team with a compliance packet consisting of Quality Plans (QP), drafted QMS procedures and reports for the following areas: Biocompatibility, Usability, Labeling, Clinical Investigation and Post Market Surveillance, Sterile Barrier Systems, to include Sterile Packaging, Sterilization, Environmental Controls, Cleanroom Biocontamination Control. All meetings and completion of assignment completed remote using WebEx applications. • In parallel a General Safety and Performance Requirements (GSPR) Gap Assessment was completed. The GSPRs were completed for several class I, II and III devices in support of EU Medical Device Regulation 2017/745 CE certification. Supported the engineering and quality staff in their assignments and reviewed the outputs for compliance throughout the project. Performed design history file reviews with gap analysis and recommendations for corrections.

Program Manager, SME Cybersecurity Regulatory Compliance for a global leader in the design, development, manufacturing, and distribution of kidney dialysis products and services.• Providing program management and subject matter expert services specific for the adoption of external standards and country specific regulations into the Quality Management System (QMS) as they apply to Medical Device Security (Cybersecurity) specific to FDA section 524B, Ensuring Cybersecurity of Devices (section 3305). Standards include IEC 80001-5-1, UL 2900-1, TIR57, TIR97, ISO 29147, and ISO 30111. • Managing the CAPA and remediation activities for those devices the adoption will affect to include Threat Modeling, SBOM, Vulnerability Testing and Security Risk Analysis. Developed a post market vulnerability disclosure program which can obtain, process, and remediate potential vulnerabilities that come from external sources as well as notify and disclose such vulnerabilities to the users.

• Within 3 months completed a full remediation of the company’s ISO 13485-2016 Quality management system to address numerous FDA 483s. A company who manufactures products intended to improve the appearance of skin. The project also delivered the drafted compliant investigations and necessary CAPA initiation documents. The entire packet was transferred to the quality organization on time to meet FDAs expectations.

• Team leader of a six-member team working off-site for a large medical device company specializing in artificial heart valves and hemodynamic monitoring. The project involved the risk file remediation of selected products whose current technical files have been maintained under the Medical Devices Directive (EU-MDD) 93/42/EEC or the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC which now needs to comply with EU Medical Device Regulation 2017/745. Current responsibilities include being the customer’s point of contact for the team’s assignments and deliverables, providing the necessary guidance to junior level team members and creating a remediation workstream, which provides the high level of quality and attention to detail that is required. The team has been recognized for its quick response in drafting the required risk files using newly released templates, setting the gold standards and providing guidance to those staff members during final approval.

• Program manager over ISO 13485:2016 Certification through the Medical Device Single Audit Program (MDSAP) for a company who is a leader in the design, development, manufacturing and distribution of dental implants, abutments and other dental products. Duties included initial GAP assessment, development of a trace matrix, project Gantt and tracking, resource planning, project risk reduction strategy, and costing. Key accomplishments included performing a Gap Analysis of the customer’s quality management system to determine the level of compliance with ISO 13485:2016 and develop quality plans with action items needed to bring the system into compliance within 7 months. Additional support included authoring key quality management system procedures as well as authoring many quality plans to address such gaps as software validation for non-product software, complaint handling, CAPA and change control. Completion of the program ended with the customer completing the third party certification audit to ISO 13485-2016 with minimum nonconformities.• Lead quality engineer for a large medical device contract manufacturer that specializes in medical components and medical devices. The assignment, lasting six months, was specific to addressing a backlog of injection molding process validations, customer complaints, responses to numerous customer audits and ISO 13485-2016 certification readiness. Assignment was successful in addressing the backlog of work in a short period of time and transferring the sustaining work to the core quality team.

Recent positions have included:• Recently lead various medical device investigations and corporate work process improvements under an FDA remediation effort that will also increase customer satisfaction and production efficiency. Performance to date has included analysis of product labeling for over 16,000 products and providing solutions with a cost saving potential of $2 million dollars annually. Credited for taking on multiple legacy issues, which had been under an improvement process for years, and within months developed the strategic plans needed to gain compromise and collaboration throughout multiple departments in order to move the issues to a successful closure.• Quality lead for the integration of a medical stent start-up company into a larger medical device company. Recently completed a detailed design history file and CAPA audit. Deliverables resulted in providing corrective actions which included process validation and test method validations. Completed several test method validation “gold” standards. Lead and completed an accelerated design for manufacturing and outsourcing project which included development and implementation of several unique test fixtures for micron- assembly and measurement. Several engineering studies were also developed to provide the correlation of an existing visual and tactile assembly process to a variable measurement fixture. Operator certification and training are also being developed leading the way to an operator self-verification program. • Project manager of a ten million dollar remediation program specific to validation of test methods involve in the manufacturing of neurostimulation and implantable drug delivery systems. Under a consent decree environment, the project required developing and bracketing of over 10,000 inspection criteria into 60 various test methods.

• Validation Project Manager with a team of over fifteen members. Responsible for the development and execution of over forty automated and manual production and test system validations. Developed and implemented the test method procedures where none existed. Project phase was completed in less than 3 month with minimal impact to production. This position required all aspects of validation to include writing, execution and reporting of the validations. • Subject Matter Expert for Process Validation; Serving as teacher/mentor for those who are less experienced on topics, techniques of process validation, statistical techniques, test method validation, and Process FMEA under ISO14971. Responsible for the review and approval of validation protocols in support of process validation efforts involving, special process, precision injection moulding systems, test method validation and high speed assembly. • Senior Engineering Consultant to advanced medical device manufactures under a consent decree and warning letter environment with a major role and responsibility on Operational Workstream improvements, which required extensive experience in Management Systems, Management Controls, and the entire Quality System. Recent work has been conducted for medical beds, implants, heart lung machines and drug delivery systems providing the appropriate procedural mapping and gap analysis specific to meeting 29 CFR 820, ISO 9001, ISO 13485, CMDCAS, MDD requirements. • Established an Internal Audit Program for a medical device company leading to the removal of a major 3rd party audit finding. Created an internal audit work stream, acting Lead Auditor performing audits per approved audit plan in support of 29CFR820, ISO 9001, ISO 13485, CMDCAS, and MDD compliance.

• Manage global projects through team building and interaction between Marketing, Purchasing, Quality Assurance, Quality Engineering, Manufacturing Engineering, and Production • Led cost reduction projects from manufacturing, customer satisfaction and service cost of ownership using Lean and Six Sigma techniques. • Managed supplier quality, performed supplier audits and supplier corrective actions. • Developer of processes, training manuals, checklist, work instructions and department procedures.

• Managed the production start up and sustainment of a specialized medical device, developed the project schedules, secured resources and managed their timely execution, completion of tasks and deliverables. • Turn keyed the design, fabrication, and implementation of assembly aids and test equipment.• Developed and performed numerous Process and Design Failure Modes Effects Analysis, as well as various statistical process control studies.

• Principal investigator for numerous product investigations.• Performed test and evaluation of various materials such as delrin, silicon, graphite and PTFE.• Authored numerous laboratory protocols, manufacturing test procedures, work instruction, checklist

Developed and led a project to resolve customer complaints, decrease direct cost of manufacturing, improve product safety, product repair cost and maintenance of a product.

• Managed development projects of several semiconductor gas delivery systems under QS-9000 and ISO-9000 requirements.• Developed drawing, department and documentation standards for the engineering department which support new products and manufacturing assembly documents.• Conducted and facilitated many Safety reviews including Hazardous and Operability Studies (HaZops), 8-D, root cause analysis and FMEA ensuring a safe and reliable product.