Jordan Hoffman Email & Phone Number

Denver, Co, Us

Boulder, Colorado, United States

- Senior Operations executive of a ~$5m/yr startup- Recruited and built a world class team of employees, consultants and advisors in the following areas: Regulatory Affairs, Regulatory Counsel, Quality Assurance, Medical Device Manufacturing, Finance and Accounting, Contract Counsel, Clinical affairs, Commercialization Strategy, IT Management, Banking, Engineering- Oversaw vendor selection, relations, contract administration, scope adjustments- Performed competition research and contributed to product development and launch plans- Managed university lease, equipment disposition and offsite storage of assets- Coordinated legal services between General Counsel, Intellectual Property, Contract and Regulatory Law firms

Boulder, Colorado, United States

- Design and Oversight of all elements of Darwin's benefits and policies- Curated a unique culture that led to 100% retention of all full time employees- Worked with finance and accounting team to design and implement best in class purchasing and expense systems

Louisville, Colorado, United States

- First employee in a company translating groundbreaking peripheral nerve research into a clinical product- Designed a novel medical device to enable efficient drug delivery in a drug-device combination product- Participated in physician training and distribution of clinical supplies for Phase 2 Clinical Trial (NCT04572906)- Designed a process by which injection molded materials could be rapidly prototyped in house, decreasing iteration cycle time by 70% and delivering a final design 50% under budget compared to traditional methods.- Solicited quotes and worked with vendors to identify a cost effective and timely method to manufacture, package and sterilize several thousand clinical kits.- Interfaced with research team to translate lab performance and testing data into effective geometry changes, based on FDA design control guidelines- Implemented Design Controls and facilitated transfer of documentation to QA in compliance with ISO 13485 and GMP

North Haven, Connecticut, United States

- Designed and ordered tests of engineering prototypes, reported results, contributed to design meetings to implement changes based on results.- Interacted with surgeons to understand how the end product was used and what portions of the user or patient experience could be improved.- Participated in a rotation with the Sales and Marketing department, gaining an understanding of how medical devices are sold and product portfolios are managed.- Researched competitive product, eventually building a referenceable database of 127 surgical ports so that management could make informed decisions and statements about the capabilities of our product as compared to the rest of the market.

Bachelor Of Science (Bs), Mechanical Engineering

In the course of taking an exceptional class load to fulfill the requirements of two separate engineering degrees, I participated.

Bachelor Of Science (Bs), Materials Engineering

Took a combination of mechanical and materials engineering classes that covered both theoretical and practical aspects of mechanical.