|Medical Device Product Development Engineer|
GeNO LLC is currently seeking a Product Development Engineer to support development and manufacturing of next generation of drug device systems. Product development experience with medical devices or drug delivery systems is required.
|Senior Mechanical Engineer|
GeNO is currently seeking a Senior Mechanical Engineer to To design, implement, and maintain the necessary systems for the manufacturing processes and quality improvement activities. Provide the necessary support to the R&D and Pilot Plant for process and quality activities. The position works under the general direction of the VP of Engineering.
|Associate Director of Clinical Operations|
The Associate Director of Clinical Operations is responsible for the day-to-day management of the direction, planning, and execution of all clinical studies conducted by the company according to company SOPs, and FDA, EMA and ICH-GCP regulations. This includes: management of all aspects of clinical trials conducted by the company and management of all vendors (CROs, clinical labs, contract monitors, medical writers, data management, etc.) associated with the planning, start-up, conduct, and closeout of the company’s clinical trials.
|Quality Operations Manager|
The Quality Operations Manager provides leadership in the development, implementation, and maintenance of quality systems, procedures, and policies to assure compliance standards for drug-device combination products. This includes but is not limited to compliance with FDA 21 CFR 4, 21 CFR 820, 21 CFR 210 & 211, ISO 13485, ICH Q7, ICH Q10 and other industry standards and guidances as required.
In addition, the Quality Operations Manager is responsible for management of 5 work streams within the Quality Assurance organization: Quality Operations, Document Management, Complaint Management, Corrective and Preventative Action (CAPA), and Training.
|Manager / Director of Manufacturing |
The Manager/Director of manufacturing is responsible for the day-to-day management of manufacturing activities and objectives established in the company’s Operations Plan. This includes: conducting all manufacturing operations in accordance with company quality policy and procedures, cGMP and ISO 13485; manage manufacturing planning and resourcing to meet clinical, R&D and marketing demands for product and services; manage manufacturing cost and continuous improvement activities.
The Manufacturing Engineer will be a core team member on multiple parallel projects or product transfers responsible for providing engineering support to manufacturing, execution of project tasks and the development of new or refinement of existing process technologies.
The Manufacturing Technician is responsible for routine manufacturing operations for the production of clinical and/or commercial products, operation of production equipment according to SOPs, and leading daily activities on the manufacturing floor.
|Senior Regulatory Affairs Associate|
Assist RA management in the development of global regulatory strategies for combination products (drug-device). Provide support for preparation of submissions (regulatory agency meeting packages, INDs, CTAs, NDAs, technical dossiers, MAAs, and ODAs). Navigate and interpret regulations and provide regulatory guidance to teams across multiple therapeutic areas.
The Materials Coordinator is responsible for receiving, warehousing and shipping materials and equipment. Additionally, this position will be supporting purchasing and inventory management functions as needed.
|Senior Mechanical Designer|
Expert with product/equipment design execution and completion to include design analysis, and generation/modification of mechanical and electromechanical products and systems. Works closely with engineering staff designing mechanisms, injection molded and metal components for product development and engineering support. This includes working knowledge of polymers, metals, coatings, treatments, and assembly/joining technologies/processes, as well as, equipment selection for prototype to pilot production and testing. Highly proficient with SolidWorks. Experience in a highly regulated environment such as medical device or pharmaceutical industries.