Don Rah Mee Row

903-***-**** •adb8g6@r.postjobfree.com• https://www.linkedin.com/in/don-r-8609b211/

Versatile Senior Operations Executive and Global Quality/Regulatory Engineer with strong operations, Gxp compliance and business acumen who drives continuing improvement in product quality and performance. An inspirational leader to and developer of high-performance organizations in engineering capital projects with as many as 200 professionals with significant International (Spanish) Medical Device product transfer experience with major Capital Equipment. Noted for providing an uncommon blend of experience in P&L/Accounting, Negotiations, Operations, Quality, New Product Development, Process Engineering, Capital Management and Strategic Planning. A turnaround specialist and natural problem solver who easily and rapidly identifies areas for improvement and their root causes and drives quality to move the organization forward.0

Setting a Foundation for Quality that Minimizes Design and Process Failures: Proficient in analyzing, authoring and updating documentation inconsistencies. An SME in Design Control, Verification and Validation, per Part 820 of the CFR, ISO 14971 and Risk Management processes as well as supplier management. A prolific author of a wide variety of Quality documentation. Highly skilled in the utilization of advanced quality/ Regulatory tools D/P/U FMEA, Risk Management ISO 14971:2016 Quality Management Systems ISO 13485, ISO-GCP.

Providing Leadership Across the Engineering Spectrum: A record of exceptional performance in Engineering roles, including R&D, SQE, Quality Assurance, Mechanical, Product, Manufacturing and Lean Process Development, DHF, TMV, Furnace Mapping, Gap Analysis and Validation Engineering.

Leveraging an Engineering Entrepreneurial Mindset: A deep Engineering background with catheters, wires, stents and other specialized Medical Devices. Adept in ensuring compliance with US, EU, MDR international regulations, requirements, and guidances. Proficient in the procurement and implementation of Capital Equipment, Facilities systems, Clean rooms Class 5-8 ISO 14644-2, cGMP, Product Transfers and Support. Core Leadership Skills

Global and Cross-Functional Team Building

Engineering Management

International Operations and Logistics Management

GXP Compliance/ Quality Management Systems

software

• Trackwise QMS

•Master Control QMS

• JDE EnterpriseOneQMS

• Ignite QMS

•Oracle QMS

• Agile QMS

• Enovia QMS

•MES Factory works QMS

• RTI - Smart Solve Solutions Database QMS

• Share point QMS

COTS Selection and Implementation

Training and Professional Development

Risk Management Gap Analysis

Project Management

Quality Tools and Quality/Regulatory Management

Technical Files / Dossiers

Asset and Vendor Management

P&L Management Budgeting Forecasting

Procurement (IQ, OQ, PQ)

Design Control, Verification and Validation

Major Capital Equipment Product Transfers

Regulatory Compliance (US, EU, MDR-AUDITOR)

Enterprise Resource Planning (ERP) /SAP

PMAs, CERs, MEDDEV 2.7.1 Rev.

Providing Quality/Regulatory Solutions that Deliver a Competitive Advantage Don Rah Mee Row Medical Device Consulting, 2009 – Present CEO

Took on a global leadership role directing the efforts of 60 FTE spread across the US, Mexico, Puerto Rico and India. Serve as a trusted advisor and strategic partner to a variety of businesses by identifying business potential and Optimizing the value of people, technology and tools through global engineering leadership in the medical device and pharma industries. developing and implementing plans to drive sustainable business growth. Specialize in providing knowledge, expertise and leadership in quality and validation roles facilitating the reprocessing of medical and orthopedic devices in compliance with cGMP, Risk ISO14971, ISO 9001, ISO 13485, IEC60601 and FDA-21CFR 820 requirements.

Meeting the Needs of Industry Leaders: Secured and managed engagements with GxP Industry knowledge supporting Life Sciences, Pharmaceutical and Medical Device technology companies, including Baxter, Medtronic, Edwards Lifesciences, Covidien, Flextronics, Terumo, Integer and RTI Surgical. In a consulting capacity served in roles including Senior Engineer, Engineering Manager, Quality/Regulatory Consultant, Test Method Developer, Senior Process and Product Development Consultant, and Product Transfer Coach.

Clinical Innovations (Six months):Served as a Senior Equipment Validation Engineer. Partnered with management to validate and streamline 13 Products in the production line. Assigned to Inventory all equipment PM’s Calibrations and classify equipment per Risk category in production floor and layout the production floor. Updated Documentation to reflect current and future state on the following documents: Material Traceability SOP’s, Clean Rooms SOP, Packaging and Delivery SOP, Material Handling, all with Master control QMS software.

Arthrex (Six Weeks):Served as a Senior Validation Engineer. Partnered with management to Validate CNCs Citizen L220X and K16E Swiss Lathes, Marvel Band Saw, Baldor Sander, Swiss Mills Hem 800 and S 400 models. Authored, reviewed, and implemented qualification and validation protocols. Provided GD&T, Gage R&R, TMV input and executed the Mini tab analysis in the report validations for the IQ/OQ/ stage.

RTI Surgical (nine months): Retained to lower the volume of Corrective and Preventative Actions (CAPAs) and non conformances, and other quality documents to a manageable level per the company’s commitment to the FDA and governing bodies. As a Senior Quality Engineering Consultant, enabled this leading global supplier of safe biologic, metal and synthetic implants to take CAPAs from 33% to a 97% closure. GVP/GCP/GCLP/GLP Drove Smart Solve software changes to enable MRP Class III software changes to Broadened the CAPA scope and capture Parent and children holds. A processes to Updated Quality Systems Manual and references to reflect current EU-MDR, GHTF and other regulations in parallel to changes to documentation in aseptic cleanroom qualifications, Classes 5, 7 and 8. Trained others in Visual Stream Mapping (VSM), Kaizen Training, CAPA Investigation and 5Ys.

Integer Medtronic (nine months): Brought on as a New Product Development Quality Consultant. Drove creation and authoring of quality transfer documents as the company was replacing machine parts with molded parts per transfer plan. Facilitated New Product Development by successfully transferring a project from Medtronic to the Integer team at 90% completion. Wrote and helped with the execution of equipment Test Method Validations (TMVs), Installation, Operational and Performance Qualification (IQ/OQs and PQ) Protocols and Reports. Authored, Master Validation Plan (MVP), Process Failure Mode Effect Analysis (PFMEA), Manufacturing Control Plan (MCP), Manufacturing Quality Plan (MQP) and Inspection method sheets to facilitate product inspections. Led Interstate, cross-functional and manufacturing, Operations, and Quality team meetings to discuss technical changes on documentation.

Terumo (11 months): Served as a Validation and Verifications Consultant tasked with updating a stagnant process and validating a CNC machine. Validated CNC part to 99.5% accuracy. Teamed with production and operations engineers to remediate Device History File and Record (DHF DHR) deficiencies. Authored and implemented equipment IQs, TMVs, OQs, and PQ Protocols and Reports. Initiated ECRs and ECOs to facilitate drawing changes and execute the above protocols per quality system. Wrote Manufacturing Work Instructions per Template. Researched and defined Gap in Process Controls. Aligned ERS and URS to with Unique Identification Numbers (UIN) Preventative Maintenance records.

Flex (five months) International Experience Product Transfer to Juárez, Mexico: Helped the third largest global contract electronics manufacturing services company to implement a product transfer to Mexico by coaching and mentoring Junior Engineers in engineering documentation work and review. Drafted URS, ERS, SATs, IQs, TMVs, OQs and PQ Protocols, and functioned as a new Product Development and NPD/SME Quality Member.

Covidien Medtronic (nine months): Partnered with a strategic business unit of Medtronic for Post Market Surveillance (PMS) to enhance its R&D efforts, ramp up production and remediate issues with quality systems. Worked with suppliers to enhance new Production Part Approval Process (PPAP) Quality Management Systems

(QMS) processes and obtain material certificates. Developed testing to support test executions with Nitinol materials.

Edwards Life Sciences (eight months): Teamed with this American medical equipment company to lower its production risk and improve its product quality. Served as a New Product Development, Quality Consultant and SME, while working with a Design Engineering and Manufacturing team to launch a new Nitinol Fastening System. Improved supplier management by aligning internal product numbers with supplier identification lot numbers in a Traceability Matrix. Worked with suppliers to determine packaging and boxing requirements on new product lines.

Medtronic (seven months): Served as a Senior Engineer. Partnered with management to improve its manufacturing strategy. Authored, reviewed, and implemented qualification and validation protocols. Provided GD&T, Gage R&R studies, TMV and Mini tab analysis. Conducted IQ/OQ/PQ/EQ, DHR to optimize procurement of new equipment. Mini tab analysis Anova, DOE, Six Sigma methodologies.

Baxter (six months): Partnered with this manufacturer of products that treat hemophilia, kidney disease and immune disorders, to update and standardize its TMVs across all product platforms. Led TMV efforts while remotely managing a team of 15 engineers. Rapidly developed an understanding of Baxter’s engineering staff, methods, techniques and theories, as well as corporate and division SOPs, policies and projects. Galt Medical, Garland, TX 2007 – 2009

Galt Medical is a leading provider of vascular and interventional medical devices utilized in interventional procedures. Galt offers its products under its own brand and to clinicians worldwide through a network of distributors. INTERNAL CONSULTANT ENGINEER

Brought in to provide leadership and support to an organization with 150 team members and five Technicians. Served on an as-needed basis in roles, including Facilities Coordinator, Logistics Manager, ERP supply chain and BOM updates, Process Engineer, Manufacturing Engineer, Construction Project Manager, EHS Specialist, Electrical Engineer and Mechanical Engineer. Liaised with regulatory, customer service, engineering, marketing and manufacturing teams to ensure superior quality in products used by clinicians in Interventional Radiology, Interventional Cardiology, Vascular Surgery and IV Therapy procedures. Boston Scientific AUG, San Jose, CA 2006 – 2007

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices. ENGINEER

Recruited to provide leadership to three junior engineers and partner with the New Product Development Team to design and develop new products. Streamlined and improved Electrophysiology Class II, III product lines and product development processes. Oversaw (PDP) product development process Integration. CAREER NOTES

Early career success as a Missionary and Capital Projects Director in Chile and in Operations and Manufacturing leadership roles with ACS Guidant Corporation and Eli Lily. At Eli Lily, pioneered the design and development of cardiovascular medical products, including artificial pacemakers, implantable defibrillators, catheters and stents for this market leader in medical devices. Planned and directed major product transfers in Class II and III Manufacturing production projects. At ACS Guidant, brought invention, innovation and technology advancement in guide wire coatings and high- pressure balloon materials enabling Guidant to grow guide wire sales by 23 and high-pressure balloon sales by 23% to $176M. Created new tooling equipment and streamlined manufacturing processes to facilitate 35% annual growth.

Education, Certifications and Expertise

BS, William Jessup University, Rocklin, CA

AS, ARTS/Graphics, University of Texas (TSC) – Brownsville, TX EU MDR Auditor (Europe’s Medical Device Regulation 2017/745) New Product Development (NPD) Product Development Processes (PDP) Test Method Validation (TMV) Good Clinical Practices (GCP) Current Good Manufacturing Processes (cGMP) Good Clinical Lap Practice (GCLP) Master Validation Plan (MVP) ISO, IEC, FDA, CFR Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Design Failure Mode and Analysis (DFMEA) Process Failure Mode Effect Analysis

(PFMEA) EQ GD&T Geometric Dimensioning and Tolerance (GD&T) Verification and Validation (V&V) Testing Production Part Approval Process (PPAP) Quality Management Systems (QMS) Director, Post Market Surveillance

(PMS) Repeatability and Reproducibility (R&R) Testing Design History Files (DHF) Device History Record (DHR) Manufacturing Control Plan (MCP) Manufacturing Quality Plan (MQP) Corrective Action Preventative Action

(CAPA) Site Validation Plan (VMP) MIni-Tab, DOE, ANOVA and Six Sigma Methodologies.

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