Tom Gerold Email & Phone Number

Eden Prairie, Minnesota, US

• Full time in this role from October 2014 to November of 2016*Founded Fixx Orthopedics, LLC, a medical device company focused on developing fracture fixation solutions to improve patient outcomes and decrease healthcare.
• Closed seed round of funding with angel investment
• Three patents issued to date (US 14/160,668, US 15/018,260, US 15/053,154)
• Created business and medical advisory boards comprised of industry veterans and leading physicians
• Pivoted company into focused product development organization; currently developing and testing a single, rotationally stable bone fixation pin

• Strategic executive leader of HLT’s research and development function concentrated on the design and development of a novel catheter-based aortic heart valve and delivery system (reporting directly to the CEO). Focused.
• Design lead and owner for the next-generation Meridian TAVR system family, a Class III implantable nitinol aortic heart valve with an electronic semi-automated delivery system
• Led design-control development and verification activities resulting in two successful Early Feasibility Study initiations (RADIANT AS and RIVAL AR trials) and 10+ successful FDA design change submissions
• Served as business representative during clinical trial site initiations, physician technology demonstrations, and patient case support in the OR/Cath Lab; had direct customer contact, conversation, and provided device.
• Hired, managed, and focused the technical staff within HLT’s R&D department, including 20 R&D / PD engineers, technicians, designers, and supervisors
• Engineering cost center owner with responsibility over a $2.2 million R&D budget; focused on organization enhancements, process development, capital equipment and component purchases, and internal/external technical.

• R&D senior leader responsible for R&D engineering team management and motivation, product development and placement strategy, and design-for-manufacturing of HLT’s next generation Meridian Valve. Cross-departmental and.
• Led a team of 10 R&D engineers and technicians to complete verification testing supporting a clinical trial; wrote several successfully approved FDA technical submissions and justifications
• Adapted HLT’s test method (R&D and within manufacturing) strategy to align with new and existing standards
• Bridged gap between R&D and Manufacturing functions; created, managed, and motivated a cross-departmental team focused on process development and design-for-manufacturing

Plymouth, MN, US

• Led all aspects of the OEM Balloons business unit, including R&D, manufacturing, sales/quoting, quality, and business development, with a focus on product development engineering. Filled a strategic and engineering.
• Hired, trained, managed, and mentored a high-performing R&D/MFG team of four to eight direct reports comprised of R&D/PD engineers, R&D technicians, R&D support staff, and operators
• Developed and executed long term strategic plan leading to early profitability and significant revenue growth; quadrupled sales over two years while transferring several R&D products to production
• Provided direct PD engineering support on medical device projects from concept to production, including concept design, device evaluation, V&V testing, IQ/OQ/PQ validation work, and production transfer
• Managed CIP and engineering teams leading to substantial margin improvements and scrap reductions on existing balloon, balloon catheter, and reinforced catheter shaft product lines

Fridley, Minnesota, US

Specialized in prototyping, development engineering, the product development process, clinical test model development, and user needs studies/testing on catheter based devices, including PTA balloons, self expanding stents, pharmacomechanical catheter-directed thrombolysis, and saphenous vein ablation. Highly focused on ideating, engineering, and testing.

- Assisted Students and Faculty with project design and fabrication- Operated and performed maintenance on manual and CNC mills and lathes- Lead training sessions on the CNC mill, manual lathe, wood shop machinery, other common power tools- Supervised and maintained the hand and power tooling checkout system

Minneapolis, Minnesota, US

- Filled a Research and Development Engineer's role in designing, modeling, and fabricating advanced vasculature models of the abdominal aortic and iliac bifurcations- Worked with FDA submission feedback to meet new FDA guidelines- Designed and created injection molds for the vasculature models using SolidWorks- Utilized clinical data and physician.

Minneapolis, Minnesota, US

- Worked in the Stent Catheter Technology group to assist in the release of a new product- Coordinated verification testing data management and performed all data analysis- Analyzed process characterization data and assisted in process development and specification placement- Filled an Engineering role to support technicians throughout testing- Developed.

Minneapolis, Minnesota, US

- Ran cost reduction project; correlated measurement of destructive testing with supplier data - Saved $20 per part + 5 hours of inspection time per lot of 25 parts - Project had an estimated annual savings of $160,000- Qualified and moved 30 parts to “Dock-To-Stock”, saving inspection time

- Coordinated, conducted, and reported gage studies (R & R)- Worked towards implementing Statistical Process Control (SPC) plant-wide- Trained all operators and engineers on the proper use of new equipment- Devised method for automated SPC data collection with a Ziess CMM