Tom Rish Email & Phone Number

Noblesville, Indiana, United States

Indianapolis, Indiana, United States

- Oversee 3 teams of medical device professionals consisting 21 employees: Onboarding & Implementation, Professional Services, and Solution Engineering.- Manage annual budget and provide strategic guidance for the team. - Create and track quarterly objectives and other important metrics for the team.- Assist with cross functional projects related to product launch, marketing, and pricing/packaging.

Indianapolis, Indiana, United States

- Managed a team of 11 medical device professions that provide quality, regulatory, and product management guidance to over 500 clients that use the company’s QMS software.- Recruited, hired, and onboarded 7 new medical device professionals to grow team from 4 to 11 people.- Created Gainsight dashboards to track important metrics for the team.

Indianapolis, Indiana, United States

- Provide quality, regulatory, and project management guidance to nearly 30 clients attempting to launch a medical device into the market.- Support the Success Operations team that collects and analyzes customer data to drive the long term product roadmap for electronic quality management system.- Member of Product Success team that develops the long term vision for the software product.- Build Salesforce reports/dashboards to help the sales team track metrics around product demonstrations.- Draft content articles and present at conferences on best practices in the medical device industry.

Indianapolis, Indiana, United States

- Assisted medical device companies throughout the world with implementing a quality management system per FDA and ISO 13485 regulations. - Provided guidance on design control and risk management activities for medical devices in development.- Reviewed and edited documentation used in regulatory submissions and pre-submission meetings.- Managed over 50 accounts that use Greenlight Guru software by training customers, providing product support, and holding contract discussions.- Managed all product support activities for the organization.- Conducted product demonstrations for prospective clients.- Worked with product development team to develop new software features and workflows.

Fort Wayne, Indiana, United States

- Led the product development team consisting of 3 engineers responsible for designing new implants and instruments used in partial joint resurfacing applications.- Fully developed and launched a partial resurfacing patella system consisting of 4 implant sizes.- Worked with domestic and international surgeon design teams to optimize implants, instruments, and surgical techniques.- Organized and led cadaver labs with design surgeons to get feedback on surgical instrumentation.- Determined regulatory strategies for new products per FDA and MDD regulations and maintained all design history file and technical file documentation.- Traveled internationally to train distributors and educate surgeons about the company's partial resurfacing implants in an effort to increase sales.- Created effective marketing materials in InDesign for use in counties throughout the world.- Quality representative in charge of audits, management reviews, and maintaining compliance to applicable medical device regulations/standards.- Managed outside vendors and responsible for ordering all outsourced instruments, cases, and implants.

Fort Wayne, Indiana, United States

- Developed new instruments and instrument case for use with a partial resurfacing shoulder system. - Developed test protocols, completed testing, and wrote test reports for orthopedic implants.- Assembled technical file and successfully obtained CE mark for partial resurfacing shoulder system.- Updated quality procedures and organized quality system to successfully pass 3 quality audits.- Updated change management system to improve compliance with ISO and FDA standards.- Updated existing implant and instrument drawings for consistency and to improve manufacturability in order to reduce costs for the company.

Warsaw, Indiana, United States

- Responsible for the design and development of surgical instruments used in total knee arthroplasty. - Attended joint replacement surgeries and discuss ways of optimizing implants, instruments, and surgical techniques with surgeons and sales representatives.- Presented the instrumentation and surgical flow of a newly released total knee replacement system to surgeons and sales representatives at medical education events.- Maintained a design history file in accordance with FDA regulations.- Developed test protocols and analyze test results as part of instrument design validation.- Completed design failure mode effects and analysis and maintain proper risk management files. - Leader of a team of engineers tasked with remediating design history files of existing products to ensure compliance with FDA regulations.

Warsaw, Indiana, United States

- Member of cross-functional team dedicated to making product design enhancements and manufacturing process improvements to reduce cost to the business unit.- Trained in GD&T in order to update prints to aid manufacturing and inspection methods.- Investigated customer complaints by completing component layouts and risk analyses in attempt to determine a root cause. Used results to create technical reports for surgeons and patients.- Assisted in CAPA investigations to determine root causes of product and process non-conformances.- Discussed with surgeons the clinical significance of using out-of-specification or incompatible devices to complete health hazard evaluations.- Worked with sourcing to transfer existing products to new vendors in an effort to reduce cost.- Instructor for a sawbones training class designed to teach new employees the surgical techniques of two of the company’s total knee replacement systems.- Managed Co-op employees including assigning projects/tasks and completed yearly reviews.

West Lafayette, Indiana, United States

- Assisted in developing a hydrogel template strategy for the production of homogeneous nano/micro-particles for use in drug delivery studies.- Performed drug delivery release studies employing the process of HPLC.