Scott Arp Email & Phone Number

Miami, Fl, Us

Miami/Fort Lauderdale Area

Engineering Serviceshttp://www.tag3engineering.com/

Miami, Florida

Medical Device Industry

Process Development Engineer. Responsibilities in the areas of device development, conformance tracking resolution of discrepant issues and CAPA’s, non conformance evaluation and disposition. Designed components and equipment using Solidworks. Overall activities consist of managing product, process, and equipment validations (IQ, OQ PQ), technical support to operations and protocol execution, development and upgrading of process procedures, ensuring compliance with all pertinent FDA and CFR 21 requirements. Process and work flow development and implementation for lean manufacturing. Led a team of (5) engineers to develop and retrospectively create all supporting documentation for test equipment, production equipment, and documentation, stability development, creation of functional design specifications, characterizations and susceptibility testing, gap risk assessments, FMEA’s/PFMEA’s, trace matrices, GOP’s IQ, OQ, PQ’s and DOE (engineering) studies for all sub components to ensure ongoing capability and compliance with FDA requirements and audit representation.

Lead Product Development Engineer for Design efforts focused on phase I and II on a Hernia Stapler with Integrated Mesh Manipulation. Efforts required extensive research with Dr. Parviz Amid, one of the top leading surgeons in hernia repair. Concepts were implemented leading a team of process, quality, and validation engineers towards successful completion of design improvement and qualification task for this new product line. This position encompassed provision of innovative design, concept and procedural development, product validation planning, and guidance for all qualification.

Process Development Engineer for a full validation remediation effort for implantable polymers. This effort led a team of engineers and in house quality to develop and retrospectively create all supporting documentation for test equipment, production equipment, software validation and documentation, life cycle development, creation of Functional Design Specifications, and Susceptibility testing, Gap Risk assessments, FMEA’s/PFMEA’s, Trace Matrices, SOP’s, WKI's, TRV's, and DOE (engineering) studies for all sub components to ensure on going capability and compliance with FDA requirements and audit representation. Resource allocation for all phases of the program and technical support to all areas.

Senior Engineer Technician for Design/Qualification/ Validation effort focused on the process and design of a newly developed Class II medical device “Inscope” Multi-Clip Applier. This position has encompassed both provision of technical support for Product development, bio-compatibility testing, and logistical guidance for all qualification and validation activities and proper quality and engineering development towards achieving certification. The focus of this effort required a through knowledge of product development, test methodology, validation principles and methods, Quality documentation and techniques as well as all aspects of Supplier chain management and surveillance pathways. Invented, designed and developed the “Inscope” flexible clip applier. Designed and machined tool equipment for process development. Facilitated in root cause analysis. Machined parts in house for development. Assisted project through transfer from Research & Development (Miami) to Manufacturing (Juarez, Mexico).

Senior Engineer Technician for Validation/ Engineering for design of a newly developed Class II medical device Cardiovascular Tissue Stabilizer and Heart Positioner device, requiring the development, preparation and execution of Commissioning documentation, specifications, manufacturing and maintenance procedures. Responsible for development of manufacturing processes to support clinical development projects. Assisted in process qualification and validation in order to meet U. S. and International regulatory requirements. Invented, designed (Pro Engineering), and developed an Endoscopic Retractable Hook and Gripper Device. Implemented process improvements that significantly contributed to the viability of cardiovascular technology. Processed and machined complex parts on a Citizen Swiss screw machine L-25.

CNC Programmer Process/Manufacturing in charge of implementing the Swiss screw machine department. Reported to the CEO with responsibilities for processing and manufacturing medical parts. Established the Swiss screw machine department. Implemented process operations and operating procedures for the screw machines. Trained personnel for operating Swiss screw machines. Operated and programmed Citizen Swiss screw machines L-25, L-20, and M-20. Worked directly with customers during process development while machining parts.

CNC Programmer Manufacturing in charge of setting up and operating Swiss screw machines. Programmed and operated Citizen Swiss screw machines, all M and L series machines. Customized turning inserts on Agathon tool grinder for special bone screw threads. Elected team leader for a group of CNC machinists on first and second shift.

A.A., Engineering

Mechanical Engineering