Tim Franklin Email & Phone Number

Indianapolis, Indiana

- Remediation of Design History Files and Technical Files- Copy, build and file DHF/TF documentation appropriate for ISO and FDA audits

Indianapolis, Indiana Area

- Assigned Operations responsibility for both Medivative and Medivative's parent company, Aircom Manufacturinig.- Designed and implemented an improved Change Control process into Aircom.- Started scheduling Aircom production per component and manufacturing lead times balancing component lead times with inventory levels to achieve the customer's desired product deliveries and service levels.

Indianapolis, Indiana Area

- Established Plastic Injection Molding capability within Medivative.- Participated in early development and initiated production planning for the Auvi-Q Drug Delivery Device.- Implemented Cold Chain transportation strategy for the drug used in the Auvi-Q Drug Delivery Device.- Developed and implemented production and departmental performance metrics collection and reporting.

Indianapolis, Indiana Area

- Started the expansion of the Medivative production capability into a second Medivative facility.- Expanded Medivative production capacity and control onto the second floor of Aircom Manufacturing.

Indianapolis, Indiana Area

- I was first full time employee hired to start Medivative Technologies’ Manufacturing Operation.- Working with the Director of Quality and Regulatory Affairs, I authored QSPs associated with Operations. - Developed a structured Part and Document Numbering System.- Designed formal meetings and agendas to establish lines of communication for and between upper management, middle management and staff.- Launched manufacturing of Hologic’s Breast Biopsy Console.

Indianapolis, Indiana Area

- Over saw the launch of several new products. One specific product of interest was a lifesaving instrument designed to clean the blood of toxins created by an overdose from prescription and over-the-counter pain medication.- Launched and managed the manufacturing of a unique devise that deployed a radioactive bead to radiate stent sites, thus smoothing the arterial wall which enhanced blood flow.

Indianapolis, Indiana Area

- Developed and implemented a risk based component purchasing process designed to reduce product launch lead-times due to long component lead times.- Assigned the responsibility to visit Roche Diagnostics’ European suppliers that provided components to the US, to audit for performance and Regulatory Compliance.

Zionsville, Indiana

- Hired to start-up and manage the manufacturing of a new Portable, Hand Held, Multi-Analyte, Test Strip Based, Meter.- Participated in the development and managed the manufacturing of an Automated Blood Serum/Cell Preparation Instrument.

Indianapolis, Indiana Area

- Partnered to start Vertical Market Computers Inc. (VMARC) resulting in one of the first lap top, rechargeable battery powered, special application computers for the insurance industry.- Named as co-inventor on patent (EP0180428A3) issued Oct. 25, 1985 for the VMARC Portable Computer.

Indianapolis, Indiana Area

- Started and grew a Manufacturing Engineering Department responsible for In-Circuit PCB Testing and Final Product Functional Testing.- Designed and implemented a formal ECO process and Document and Change Management System.

Indianapolis, Indiana Area

- Installed first automated blood analysis equipment and capability in Puerto Rico.- Designed and implemented an automated ignition process control for a then state-of-the-art Flame Photometer.

Bachelor Of Science (B.S.), Business Administration

Master Of Business Administration (M.B.A.)

Associate'S Degree, Electronic Engineering Technology

Certificate, Lean, Advanced Manufacturing

Principals of Lean Manufacturing, 5S System-The Visual Workplace, Principals of Value Stream Mapping (VSM), Quick Changeover/Set-up.