Robert M. Carroll

**** ********** ****

Cincinnati, Ohio 45231

513-***-**** Cell 513-***-****

acznii@r.postjobfree.com Email

PERSONAL SUMMARY

Mechanical Engineer with hands on experience providing Engineering and Management skills developing new technologies to increase a company’s profitability for the future.

PROFESSIONAL WORK SUMMARY

Management Experience:

Department Director (P&L responsibility).

Department Manager – Direct supervision of salary, hourly, and contract personnel.

Engineering Experience:

Departmental /Corporate Resource and Budget management.

Project Resource management, scheduling and procurement activities.

Project justification and cost estimation.

Design of patient / instrument positioning systems for Medical Devices.

Design of packaging and support systems.

Design of injection molded plastic components.

Design of vacuum formed plastic components.

Sonic welding of plastic components and assemblies.

Heat staking and component insertion of plastic assemblies.

Injection molding and extrusion processing of plastic components.

Design of sand, permanent mold and investment castings.

Design of hydraulic components and systems.

Optical sensor design application.

Structural Analysis.

Capital equipment justification and acquisition.

Tool, fixture and interchangeability gage design.

Failure mode and effect analysis.

Component / product routing and process control.

Reliability engineering for components, materials, products and systems.

Equipment setup and line trouble shooting.

Metal fabrication and laser cutting technology.

AutoCAD / Solid Works/ Pro-E, Lotus, Microsoft Word, Microsoft Project and Excel.

Patent applications and infringement search for medical devices.

Equipment (IQ, OQ, PQ) and Process Validation.

Design Control Procedures for Class I &II Medical Devices.

Design History and Device History Files for Class I &II Medical Devices.

Product Safety Testing and Analysis.

Application of Lean Manufacturing Methods.

GD&T drawing symbol experience in Medical Devices and Aerospace applications.

Compliance Experience:

FDA – GMP, UL 544, UL 2601, CSA 125, EMC testing, CE mark, ISO 9001, EN46001

WORK HISTORY

Carroll Technical Services Cincinnati, Ohio 7/02 – present

Private Consultant –Design, Manufacturing & Compliance (Home Business)

Contract Mechanical Engineer (Adecco) Zimmer

SME (Subject Matter Expert- Team Lead)) for Project Trident remediation involving review of control documents relating to all obsolescence activities. Design History Files including scope sheet preparation, Design Control Traceability Matrix, Change Control History, Design Transfer, CAPA activity, Customer Field Complaint audits, Field action audits and providing regulatory advice regarding field distribution.

Contract Mechanical Engineer (Maetrics) Depuy Synthes

SME (Subject Matter Expert) for Legacy review activities for Global Remediation Quality Plan. Remediation review for all acceptance activities regarding Work Stream 3.3 which included Calibration, Device History Files and Instrument Raw materials. Finalized remediation reports and developed summary reports for these activities per CAPA -001254 requirements.

Contract Mechanical Engineer (Knowledge Services, Inc.) Hill-Rom, Inc.

Acceptance Engineering Assignment for gap assessessment of all product final assembly compliance qualifications. Issued detailed report out lining identified areas of non compliance. Provided documentation support for DHR’s, DMR’s, product releases, travelers, job instruction,test specifications, controlled data collection and equipment / process validation evaluation. Participated in CAPA 1588 activity for the product final assembly procedures and CAPA closeout.

Contract Mechanical Engineer (Black Diamond Networks) Ben Venue Laboratories, Inc.

Participated in gap assessessment for equipment qualifications allowing release to manufacturing of four packaging lines. Equipment evaluated included the Dividella NeoTop 304 cartoner, Newman Labellers, Dibrico inspection systems, coders,vial washers, bar code readers and portable conveyor units. Period review performed on all portable equipment. Generated drafts for equipment protocols for heat tunnels. Generated Risk assessments for heat tunnels and rational for equipment classifications. Developed URS for portable equipment. Generated Documents to migate equipment risk factors. Generated documents for FDA Guidance relating to decommissioning of out of service equipment.

Contract Mechanical Engineer (Oxford International) for Diagnostic Hybrids Inc.

Responsible for overall project engineering support. Developed Product Life Cycle Documentation for entire Bobcat Project. Over site for all vendor sources during development and manufacturing phases. Provided advisement for all regulatory compliance actitives. Developed intellectual property documentation for issuance to legal team representing Diagnostic Hybrids Inc. Provided recommendations for stream lining product development cycle and documentation to improve product manufacturability and reduce development cycle costs and time line. Developed validation and verification documentation for Design History File. Developed performance acceptance criteria for Bobcat Medical Device.

Contract Mechanical Engineer (Oxford International) for Ametek.

Responsible for packaging assembly components for gas analyzer. Developed component designs in Solid Works and AutoCAD format for design validation and first article.

Contract Packaging Engineer (Oxford International) for CSL Behring.

Designed tamper proof carton for Helixate. Developed automated packaging line for all products and instituted 2 D matrix barcode system for product tracking. Developed container for liquid Zemaira and executed 6 container integrity studies. Developed specifications for syringe filling line equipment.

Validation Consultant Engineer for Boston Scientific.

Developed equipment list based upon Master Validation Plan criteria. Engineering rational applied to each type of equipment. Generated IQ Reports, Equipment Calibration and Maintenance supporting documentation for Retrievals Production area. Interfaced with Metrology Department for equipment calibration specifications.

Medical Device Consultant (Carroll Technical Services clients)

Developed and validated proof of concept of various medical device designs. Provided written validation for product and equipment performance performance for trocar assembly device. Developed new product proposals, provided manufacturing support, tool and fixture development, DFA / DFM for all contract jobs. Provided total project input for the development of an Adjustable Annular to repair the mitral valve (Mitral Solutions, Inc.). The device is inserted through a catheter utilizing a miniature flexible shaft design in conjunction with sensor touch placement. Developed design plan for Renaissance Radiation Therapy Unit integrating into a split MRI Unit. The radiation Unit targets specific localized cancer cells without destroying healthy tissue (ViewRay Inc.). Developed innovative product for Food industry. Sales potential exceeded $20,000,000. Advisement regarding various subject matters including compliance, design, patent issues and product cost reductions.

ACMI Norwalk, Ohio 5/04- 12/04

R&D Manager- Endoscopy Product Development

Responsible for Endoscope development and production implementation of all Rigid & Semi-Rigid scopes. Developed prototype autoclavable MR6 Semi-Rigid scope for patient use in urology applications. The outer sheathing was an injection molded component. Development time was reduced from 18 months to 6 months by utilization of a fast track scheduling concept developed by myself. The estimated cost to manufacture was reduced by 40%. Direct Supervision to R & D staff of Product Development and Design Engineers.

Medex, Inc. Dublin, Ohio 10/01- 7/02

Principal Mechanical Engineer - R. & D.

Direct Supervision to R. & D. Mechanical Group. Direct Responsibility for product compliance, patent infringement search, product testing, Engineering protocols and product development cycle. Developed Closed Blood Sampling Set for intravenous use utilizing an integral reservoir/sampling site combination. Developed low cost pressure infusor device for annual cost savings of $500,000.

Reliance Medical Products Mason, Ohio 4/90 - 4/01

Director of Engineering

Direct supervision to R & D. and Manufacturing Engineering Departments.

Developed new products interfacing with Marketing /Sales, Manufacturing and Quality Assurance. Responsibility for all product compliance testing.

Implemented Design Control Documentation for ISO 9001 / EN46001 Registration.

Direct involvement in all projects including the selection and procurement of vendors and outside tooling. Successful placement of cost reduction programs. Implemented GD&T documentation program for all products.

Reduced cost of instrument stand and provided a $900,000 cost savings.

Achieved $130,000 Department cost reduction 3 years straight (1998, 1999 & 2000).

Patent for FX 920 Power Tilt Chair with unique patient positioning function.

Power Tilt Chair sales exceeded $5,000,000 the first year introduced into the market.

Valco Cincinnati Cincinnati, Ohio 7/85 - 4/90

Senior Design Engineer

Designed unique adhesive dispensing machines for food, corrugated packaging, book bindery systems and frozen food cartons. Total yearly sales exceeded $2,000,000.

Leyman Manufacturing Company Cincinnati, Ohio 8/83 - 7/85

Engineering Manager

Direct Supervision to Department personnel.

Designed innovative 3000 lb. and 4000 lb. hydraulic powered lift gates for transportation industry to replace current product line. Product sales increased by $3,000,000 per year. Net profit increased by 50% to $1000 per lift gate.

Cincinnati Electronics Cincinnati, Ohio 12/80 - 8/83

Tooling Engineer

Designed fixtures, interchangeability gages, and special tooling required for the manufacturing of the Singaars Satellite Communication System, Bancroft Communication System and PRC-70/77 Communication devices. Generated drawing documentation in GD&T symbol format.

LeBlond Machine Tool Company Cincinnati, Ohio 3/80 - 12/80

Manufacturing Engineer

Developed process plans for metal components used on Manual Lathes, CNC Lathes and Crankshaft Machines. Designed jigs, fixtures and special tooling for various machines.

Implemented cost reduction programs on all products. Yearly cost savings were $30,000.

KDI Precision Products Cincinnati, Ohio 12/77 - 3/80

Manufacturing Engineer

Developed routings, process plans and designed tooling to manufacture explosive fuzes

Developed and implemented tooling for efficient manufacture of Reynolds’s Metals components. Achieved yearly savings of $250,000.

Assigned to the Multiple Launch Rocket System commanding total responsibility for the

manufacturing development program. Developed manufacturing program for the safety and arming

device electronics control package on the Hellfire Missile System. GD&T drawing symbols were required to complete the final drawing documentation.

Kenner Products Cincinnati, Ohio 8/76 – 12/77

Product Engineer

Responsibility for manufacturing and cost of thirteen new products. Acquired Golden Bookmobile Project from R&D to correct design and quality issues. Redesigned injection molded components for high reliability and reduction in unit cost. The product quality index level was improved from –270 to + 72. Total program cost was reduced by $1,000,000 per year.

EDUCATION

BSME - University of Cincinnati – Technology major 1971 - 1976

LEADERSHIP POSITIONS / ACCOMPLISHMENTS

Manager of R&D Engineering – ACMI – 5/04 – 12/04

Owner – Home Based Business – Carroll Technical Services - 7/02 – present

Director of Engineering – Reliance Medical Products – 4/90 – 4/01

Engineering Manager – Leyman Mfg. Co. – 8/83 – 7/85

Sole Inventor - Examination chair with lifting and tilting mechanism for the Medical Industry. Patent Numbers 6,106,065, 6,382,725.

Mechanical Medical Device Engineer Biogrophy Addendum

15 Years Experience in FDA Regulated Medical Device Companies

UL Product Compliance Certification / Listing

CSA Product Compliance Certification / Listing

CE Marking of Medical Devices

Design History and Device History Files

Design Control Documentation

FDA 510K Submittals

FDA Audits

Implementation of ISO 9001 Standard

Implementation of 21 CFR820, Part 11.

Implementation of ISO13485 Standard

FMEA – Failure Mode and Effect Analysis

Product Development Cycle

Component Design

Proficient user in Auto Cad and Solid Works

Extensive Background in Metals, Plastics, Castings and Machining

Project management

ETO and Gamma Sterilization

Product Safety Testing and Analysis

Design of Packaging and Support Systems

Sonic Welding of Plastic Components and Assemblies

Metal Fabrication and Laser Cutting Technology

Reliability Engineering for Components, Materials, Products and Systems

Patent Applications and Infringement search

Equipment (IQ, OQ, PQ) and Process Validation

Application of Lean Manufacturing Methods

GD&T Drawing Symbol Experience

Component / Product Routing and Process Control

Heat Staking and Component Insertion of Plastic Assemblies

Clean Room Work Applications

Tool, Fixture and Interchangeability Gage Design

Calibration Documentation

Sole Inventor of (2) Medical Device Patents

Sample Activity List

Lead contact for FDA audit on medical device with reportable incident. Result: End user responsible for misuse of device per FDA final report.Company found to be compliant with all regulations. Lead contact for UL submissions and FDA regulatory requirements. Developed Design Control procedures for product line. Initiated and implemented Design and Device History Files. Direct responsibility for CE Marking documentation.

Lead Engineer at disposable device manufacturer for submittal of Class II device to FDA for reporting status. Device was classified as exempt under FDA regulation guidelines. Company’s Device was listed as Class II non exempt for ten years prior to the submittal. Authored and executed PQ’s for existing product lines.

Engineer Manager at Endoscopic Device Manufacturer. Provided support documentation for 510 (k) submittal of Class II medical device.

Validation Consultant for major medical device manufacturer. Developed IQ format content and attached documents for IQ and OQ remediation validation documentation. Products included urology stents, dilators, sheaths, balloons for stents and stone removal devices. Equipment validated were heat treat ovens, fixtures, sonic welders, tube cutters, drilling equipment, arbor presses, air presses, solder stations, heat guns, bending and forming equipment and fume removal and filtration units. Evaluated and developed equipment list for Master Validation Plan in response to Validation Remediation requirements.

Validation Consultant for major Pharmaceutical manufacturer. Developed and executed protocols for container enclosure integrity studies. Reviewed Technical Reports for submittal to FDA audits pertaining to medical devices and packaging.

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