Lead Medical Device Mechatronics Engineer

James D. Lattimore

**********@*****.***

Phone 727-***-****

SUMMARY OF QUALIFICATIONS:

30+ years engineering and product development experience of increasing responsibility resulting in over 25 successful product launches, many patents for new devices and technology, and several group turnarounds.

20+ years of engineering management experience managing cross-functional teams with 20-70 staff members of systems, software, GUI, mechanical, electrical, firmware, engineers, designers; as well as project managers.

20+ years leading medical device development resulting in 12 instrument or system introductions at major medical technology providers such as Eastman Kodak, Johnson & Johnson, Baxter, Smith & Nephew, Hill-Rom, Covidien, and several new leading edge technology startups.

Key member of a founding leadership team that grew a company to over $85M in just over 3 years.

Proven track record of successfully leading engineering groups to deliver quality products on time and on budget.

Hands-on, customer-focused, technical leader with acute business acumen and the unique ability to inspire development teams to perform at high levels while delivering leading edge technology to market.

Expert in the development of plastic components often used in instruments and disposables for the medical device and health care industry.

Broad background of engineering and management experience including hardware, mechanical, electrical, GUI, software, materials and processes, systems engineering, international safety and certification, and product industrial design.

Broad industry engineering experience including medical device, telecommunications, industrial automation and controls, machine, and consumer product design, as well as use of advanced CAE/CAD/CAM software; with industry leaders such as Westinghouse, Lucent, McDonnell Douglas, Johnson & Johnson, Baxter, Eastman Kodak, and Hill-Rom.

Education:

Master of Science in Management of Technology; University of Miami

Bachelor of Science in Engineering: Mechatronic Systems; University of North Carolina-Charlotte

Work History:

02/22 to 06/22: Arthrex-Sr Principal Design Engineer dba Lattimore Medical Design

Designed a new autoclavable reciprocating saw for use in orthopedic surgery using Solidworks 2022. The device used a planetary gearbox and a cam like mechanism to convert rotational motion to linear reciprocating motion at 16K CPS. Developed the System Requirements and the Risk Assessment for the device as well. Designed several different methods for replacing the blade using just two hands while reducing risk to the patient and user.

05/21 to 11/21: First Wave Technologies-Sr Principal Design Engineer

Oversaw the development of a new Anesthesia Workstation to facilitate efficient and safe introduction of anesthetic gases to patient’s airway for sedation. Developed the System Requirements and Architecture documents and insured the device would meet regulatory requirements such as ISO 60601-1. Designed all system plastic disposable components for minimal cost to tool and mass produce. Played a key role in component and vendor selection, especially the plastics tooling and molding, and contract manufacturing vendors.

09/20 to 4/21: Virtuoso Surgical-Sr Principal Mechatronics Engineer dba Lattimore Medical Design

Led the development of a visually guided robotic surgical system used in minimally invasive soft tissue surgeries. Worked from System Requirements and Architecture documents to design the Surgical User Interface, the Robot Cart, and all the plastic components used in the Disposable Tool Drive Cartridge for all the surgical tools. All 3D system design was done using Solidworks 2021, with the objective to meet all the regulatory requirements embodied in ISO 60601-1. Led a team of electrical, mechanical, systems, and software engineers to complete the design, system integration, and test of all subsystems needed to demonstrate basic functionality and manufacturability of the novel new surgical system in 6 months. Played a key role in component and vendor selection for key components such gears, drives, controls, plastics tooling and molding, and contract manufacturing.

04/19 to 04/20: Mirus Medical-Sr Principal Mechatronics Engineer & Director of Surgical Robotics R&D

Led the development of 3D navigation guided robotic surgical systems used in the accurate placement of bone screws needed for spinal implant surgery constructs. Worked with leading surgeons experienced in robotic surgery to define system requirements and key features, and managed hardware, mechanical, and software engineers to deliver a demonstrable proof of concept system for demonstration at the leading Spinal Surgery conference (NASS). Led the definition of system design, including system architecture, project planning, technology partner selection, design of key mechatronic sub-systems, and system industrial design. Designed all system plastic enclosure components to be molded using RIM technology.

09/17 to 03/19: Calvary Robotics-Intune Products (Webster, NY), Principal Product Development Engineer

Led the design of mechatronic systems for automated medical device inventory, storage, and retrieval; robotic assembly work cell platforms, as well as a luxury wine cabinet that featured a collaborative robot providing the motion. Used Solidworks for 3D design and analysis, Universal Robot UR3, Cognex Imaging and Lighting, Technic motors, and controls. Designed all plastic parts for the system to be molded in ABS or POM.

05/13 to 09/17: Contract Sr Principal Engineer of Medical Devices (dba Emerald Planet Innovations, LLC)

- Principal Engineer at Lighthouse Imaging: led the electromechanical development of a dual channel 1080p endoscope providing high resolution 3D imaging for a robotic surgical system.

- Technical Lead and System Architect at Phillips Medisize: led the development of a combinational drug delivery device that automatically dispensed drugs into the patient’s airway using electromechanical mechanisms and synthetic jetting technology.

- Sr Principal Engineer at Covidien: led the development of a major electromechanical subsystem used to mount, position, and providing stable support of up to 4 robotic arms used in a user configurable robotic surgical system.

-Staff Mechanical Engineer at Depuy Synthes: designed bone screws, plates, and instrumentation used in Orthopedic Trauma surgical cases.

- Sr Principal Engineer at Sequel Medical Design: designed several electromechanical devices, surgical implants and instruments, electronic diagnostic systems, and imaging systems. Including plastic instrument cases and disposable components.

All products were designed and analyzed in 3D using Solidworks or PTC-Creo. Named as the primary inventor of several patents awarded and/or pending.

05/11 to 02/13: Hill-Rom (Batesville, IN), Project Manager

Led a $14M development project and cross-functional engineering group of 35 engineers in development of a new leading edge global bariatric bed product. The product which embodies a user controlled adjustable electromechanical frame which supports patients up to 1000 pounds; as well as self-propelled transport, a motorized expandable sleep deck, integrated electronic scale, and a computer-controlled mattress that provides patient with skin care and pulmonary therapy. The product is a class 2 medical device designed for compliance to the latest FDA and IEC 60101-2 3rd Edition regulations and ISO 13485 standards. Primary inventor of two new product innovations that have been awarded patents.

06/08 to 05/11: Emerald Planet Engineering LLC (Safety Harbor, Fl), President & Principal Engineer

Led the design, engineering, and project management activities for electromechanical and electronic product development such as electromechanical medical devices as well as automated machines and instruments. Led an engineering team from customer requirement definition to system integration of a hand-held test instrument for a leading portable optical telecommunications test instrument provider. Completed a new product design of a negative pressure wound therapy dressing system including all plastic system components for Smith & Nephew and leading its transfer to contract manufacturing with on time and on budget development. Led the development of several devices and new research technologies for use in patient procedures or clinical research by doctors, clinicians, and researchers for Mayo Clinic Division of Engineering.

7/06 to 5/08: Baxter-Renal (Pinellas Park, Fl) Global APD Platform R&D Director

Led cross-functional teams in the development of new automated peritoneal dialysis systems and the sustaining of the installed base. The new system developed was the first in over 10 years, requiring an engineering team of over 45 members. We successfully completed the design in preparation for verification and validation for the 510(k) submission within 18 months. The new system was designed to satisfy the global market and simplify operational logistics while greatly enhancing the patient’s therapy experience. This was through an improved user interface utilizing color graphics and voice guidance, dramatic noise quality improvements, and significant reliability and serviceability enhancements. This position had global responsibility for product and regulatory acceptance with a budget of over $8M per year.

5/05 to 6/06: Alcatel/Lucent-RFS Conditioning (Meriden, CT), Executive Program Manager

Responsible for leading business unit department heads and their staff in transitioning all products to meet the EU RoHS and WEEE directives. My activities included generating plans, processes, project schedules, executive reports, and managing the project activities for the entire business unit. The ultimate objective in being WEEE compliant in 3 months and RoHS compliant on over 300 products in 12 months. Became expert in design for RoHS compliance, while mitigating the impacts on the global homologation requirements for electronic products caused by the RoHS/WEEE directives.

8/04 to 3/05: Digital Lightwave Inc. (Clearwater, Fl) Staff Vice President

Responsible for investigating corporate wide product quality, cost, and delivery issues and ultimately developing strategies for getting them back on track. Interfaced with every department in the organization to uncover causes of customer complaints or product issues and delivered detailed plans for their mitigation. Produced a plan to implement a data collection system and database to track component and product quality from incoming inspection through end-of-life with the customer. Conducted detailed research on the impact of the EU RoHS/WEEE directives on the business and produced a detailed plan to minimize those impacts. Often participated in new product concept or development planning and assisted with the resolution of engineering schedule problems and product EMC compliance issues.

7/03 to 8/04: CME (St. Petersburg, Fl) Director of Engineering

Responsible for managing a 70 person-engineering group which generated $14M in defense related contract engineering revenue per year. My department provided the engineering staff to support over 12 simultaneous research and development programs. These programs were primarily involved in power management, surveillance, radiometry, telemetry, sensor, and monitoring systems. Revitalized the organization by recruiting and hiring managers in the electrical and software areas to help create a more accountable and productive team and by putting into place new processes and tools. We successfully implemented and achieved ISO9000 certification in less than 6 months. Engineering maintained a 98% on time delivery of projects and other deliverables under my management.

12/97 to 5/03: Digital Lightwave Inc. (Clearwater, Fl), Director of Engineering

Participated in building Digital Lightwave’s engineering group from the ground up. Recruited and hired personnel, set up processes and procedures, and acquired tools and systems to build a world class development team geared for rapid product development of high density portable and integrated optical telecommunications instrumentation. Under my management the organization consisting of over 60 engineers, designers, and technicians has averaged a major new product introduction every six months. We consistently delivered products, which met all requirements and cost objectives. The business grew from $10M to $100M sales in three years. CEO recognition award received for engineering’s zero non-conformances in year 2000 ISO 9000 audit. Patent awarded for device idea used in a rack mounted instrument, another pending. Acted in the role of Vice President of Research & Development for the last year of employment while we downsized the engineering group to 6 engineers.

4/92 to 12/97: Johnson & Johnson-Critikon (Tampa, Fl); Sr Project Engineer & Project Lead

Responsible for managing the development and engineering of instruments used in the monitoring of vital signs of medical patients. Managed the patient monitoring electromechanical development group including several engineers, designers, and technicians. Worked closely with marketing, customers, and industrial designers to establish product development specifications, budgets, schedules and design strategy for a team to develop both integrated and modular electronic patient monitoring instruments. Lead the introduction of state-of-the-art tools (i.e., Pro/Engineer, Mechanica, & Mentor Graphics) and processes to design analyze, and prototype plastics and die-cast enclosures, and electronic circuits used to produce our products. Using this technology and facilitating high performance development teams we were able to produce high quality products in less than 6 months and on budget. Two patents were awarded for devices and mechanisms invented.

9/87 to 4/92: Eastman Kodak- Health Sciences, Custom Equipment & Mechanization,

and Business Imaging Systems (Rochester, NY) Senior Project Engineer

Responsible for establishing methods and standards at Kodak Custom Equipment, Business Imaging and Health Sciences Divisions for the effective use of Unigraphics II and Pro/Engineer for the three-dimensional (3D) design, documentation, and production of their products. Responsible for managing the development of a auto-loader for a computer radiography system. Entailed conceptual design, cost estimation, DFMA, and CAD system database procedures for the product. Also played a primary role in the engineering of the system, including, drive-train and mechanism design, sensor selection and for computer control and interface. Used Unigraphics II CAE/CAD/CAM for machine design and layout. Involved in several areas of development and engineering on projects designing instrumentation and business machines. Used CAE tools such as Nastran, Hypermesh, and Mechanica to perform analysis of parts and assemblies. Designed high-speed drive and sensor systems for optics positioning on a $1M+ instrument designed to measure film quality in real-time at all EK film production facilities. Responsible for all structural foam enclosure components and thermal management system for the EK Advanstar digital microfilm scanner printer. Three patents awarded for mechanisms or systems developed and used in products.

Education & Professional Training:

Master of Science in Management of Technology; University of Miami

Bachelor of Science in Engineering-Mechatronic Systems; University of North Carolina-Charlotte

St. Petersburg College - Human Anatomy & Physiology I & II (w/ Labs)

Geometric Dimensioning and Tolerancing (ANSI Y14.5M-1982) by Lowell Foster

Eastman Kodak - Linear Finite Element Analysis Methods

Rochester Institute of Technology - VLSI Design, CAD/CAM and NC Programming

Project Management Book of Knowledge Training and PMP Certification

UL 2601-1 Product Safety Training (UL)

Designing for EMC in Medical Products (Tektronics)

Project and Risk Management Training

Human Factors for Medical Devices (FDA)

Software Tool Proficiency: ProE/Creo CAE/CAD/CAM, Solidworks CAE/CAD/CAM, Unigraphics (NX), TeamCenter, Ansys, Flotherm, COSMOS, Nastran, Agile, Mentor Graphics, ORCAD, SAP, MS-Project, MS-Office

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