Jon Nicholas Email & Phone Number

Gore Internal Ventures (Elkton, Md)

Supporting new business opportunities within GORE Ophthalmology (an Internal Venture).

Pharmbio (Elkton, Md)

I supported the manufacturing and commercialization of GORE™ ImproJect™ Plungers within PharmBIO. I provided day-to-day support of molding unit op and supply chain. And I developed product testing and validation strategies, and successfully drove execution, to support the growing business.

Elkton, Md

I performed as a project manager within a PMO leading multiple new product development and merger & acquisition efforts (Class I to Class III products). I enjoyed the reward and challenge of leading cross-functional teams in a matrixed organization to achieve business objectives and support individuals. I successfully guided project teams through scoping phase, recovered a high-risk & stalled commercial transfer, and led multi-million dollar design control projects. I utilized my emotional… Show more I performed as a project manager within a PMO leading multiple new product development and merger & acquisition efforts (Class I to Class III products). I enjoyed the reward and challenge of leading cross-functional teams in a matrixed organization to achieve business objectives and support individuals. I successfully guided project teams through scoping phase, recovered a high-risk & stalled commercial transfer, and led multi-million dollar design control projects. I utilized my emotional intelligence, business acumen, technical and quality system expertise, and project management tools (MS Project, Sharepoint, Visio, MS Teams) to deliver business outcomes while creating inclusive, high-performing teams. Show less

Medical Products Division (Flagstaff, Az - Remote)

I moved into the Regulatory Affairs function to develop skills in another key business department within the medical device industry. I was responsible for maintaining and gaining global regulatory approval for Class III vascular device-drug combination products (implantable grafts / stent-grafts coated with CBAS Heparin Surface). I helped the company recognize its combination product designation, provide associate and executive training, and led a program gap analysis to ISO 12417, ICH, and… Show more I moved into the Regulatory Affairs function to develop skills in another key business department within the medical device industry. I was responsible for maintaining and gaining global regulatory approval for Class III vascular device-drug combination products (implantable grafts / stent-grafts coated with CBAS Heparin Surface). I helped the company recognize its combination product designation, provide associate and executive training, and led a program gap analysis to ISO 12417, ICH, and 21 CFR 211 regulatory requirements. I also authored and reviewed technical content for FDA 30-day notices, FDA PMA submissions, and global re-registrations in Europe, China, Taiwan, Mexico, and other regions. Show less

Medical Products Division (Elkton, Md)

I successfully served as the quality engineering lead on development of a next-generation delivery system for a biliary stent graft. I was involved on the project from prototyping and market research, through design control and FDA 510(k) submission, and up to commercial launch. I developed expertise in design control, design verification testing, test method development, risk management, and project management.After launching the new delivery system, I moved on to a breakthrough… Show more I successfully served as the quality engineering lead on development of a next-generation delivery system for a biliary stent graft. I was involved on the project from prototyping and market research, through design control and FDA 510(k) submission, and up to commercial launch. I developed expertise in design control, design verification testing, test method development, risk management, and project management.After launching the new delivery system, I moved on to a breakthrough endoscopic bariatric NPD project. I gained experience on a first-in-human early feasibility study and early product development. As part of a multi-site US development team, we rapidly worked on design iteration utilizing benchtop models and animal studies. I continued to develop expertise in risk management and leading core team & extended team members. Show less

Medical Products Division (Elkton, Md)

I provided a wide range of engineering support for an endoscopically delivered biliary stent graft. While supporting this product, we experienced increased sales and added a 2nd manufacturing shift. I developed skills ranging from process validation execution, root cause analysis, non-conformance report (NCR) resolution and engineering and quality system review. As a result of successfully maintaining and improving the manufacturing process, I was assigned as the technical lead on a FDA… Show more I provided a wide range of engineering support for an endoscopically delivered biliary stent graft. While supporting this product, we experienced increased sales and added a 2nd manufacturing shift. I developed skills ranging from process validation execution, root cause analysis, non-conformance report (NCR) resolution and engineering and quality system review. As a result of successfully maintaining and improving the manufacturing process, I was assigned as the technical lead on a FDA submission to obtain a new clinical indication for the device. Show less

M.S.E., Mechanical Engineering

B.S.E, Biomedical Engineering