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.

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.

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.

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.

M.S.E., Mechanical Engineering

B.S.E, Biomedical Engineering