We are a rapidly emerging biopharmaceutical company committed to developing innovative therapies that merge medicine with technology.
We seek to transform the standard of care and improve patient outcomes in major therapeutic categories for serious chronic diseases, such as diabetes. We successfully completed our Phase 3 clinical trial program for our lead product, ITCA 650, and submitted our New Drug Application filing in the U.S. in 2016.
Additionally, we are developing a pipeline of products for our proprietary Medici Drug Delivery System, comprised of three unique technologies: 1) A stabilization technology that allows for proteins, peptides, antibody fragments, and other highly potent small molecules to be stabilized at or above human body temperatures for up to three years or more; 2) A matchstick-sized osmotic mini-pump that is placed just under the dermal layer of skin to deliver a continuous and consistent flow of medication; and 3) A placement technology including proprietary tools designed to provide an optimal user experience.
We Are Growing
Since our 2012 round of financing, much progress has taken place, including significant enhancements to our world-class manufacturing facility, the opening of our new headquarters in Bostons Innovation Center, and the diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities and experiences.
A key element of pride during our progress has been our ability to remain fully independent throughout our rounds of financing so that we continue to have full strategic and executional control over all aspects of our rapidly evolving business. While we are always accountable to our stakeholders, we are and intend to remain the driving vision and force behind our progress and our ultimate success.
As a key member of the Quality Assurance Team, the Senior Quality Engineer, Medical Deviceis to assume a lead role in providing Quality Engineering support for New Product Development projects. The Senior Quality Engineer is responsible for facilitating compliance to applicable internal and external requirements during the product development cycle and commercialization of new products.
Duties and Responsibilities:
Responsible for day-to-day administration of the QMS and in the development, implementation, and maintenance of QMS processes to meet the requirements of U.S. FDA (e.g. 21 CFR Part 820, Part 4), and other applicable quality and regulatory standards (e.g. ISO 13485, MDD, ISO 14971).
Education and Experience:
San Jose, San Francisco Ca
Phone: 866 816-1615 x 823