Senior R&D Engineer (Job Code: 2014-1) ViaCyte
THIS JOB HAS EXPIRED Company Overview
ViaCyte, Inc. is a preclinical regenerative medicine company focused on diabetes. Our therapy is based on pancreatic beta cell progenitors derived from human pluripotent stem cells. These cells are implanted within a durable and retrievable encapsulation device. Once implanted and matured, these cells secrete insulin in response to blood glucose levels. Our goal is long term insulin independence without immune suppression, and without hypoglycemia and other diabetes-related complications.
The Senior R&D Engineer will be a key contributor to an expert, driven, cross-functional team focused on bringing a potentially revolutionary bio-artificial pancreas therapy to diabetic patients. The individual in this position will contribute to the design and development of manufacturing methods, documentation and validation for a system to formulate, package and preserve our novel combination product. Primary responsibilities will include the following:
Design, develop and implement novel cell/medical device combination products, components, and manufacturing processes by generating concepts and prototypes, performing pre-clinical evaluations and transferring results to manufacturing. Facilitate manufacturing transfer by utilizing principles of Design for Manufacturability. Maintain accurate documentation of concepts, test methods, drawings, and processes.
Write, maintain and execute R&D project plans and coordinate cross functional team development activities. Provide status updates to engineering, cross-functional and senior management teams.
Lead execution of design control activities compliant with the FDA Quality System Regulation and the Medical Device Directive (including ISO 13485) such as authoring and, as necessary, executing requirements documents, design verification & validation protocols, IQ/OQ/PQs and reports, risk analyses and design, and process FMEAs.
Provide engineering expertise in support of existing manufacturing activities and develop new clinical manufacturing processes, equipment and tooling. Write manufacturing documentation (BOMs, SOPs, batch records, test records, raw material specifications, drawings and other documentation), perform process qualifications/validations and support feasibility builds.
Identify and solve technical problems at the component and system level during preclinical development and clinical production phases.
Our work environment is fulfilling for a hands-on, highly motivated engineer who is willing to tackle a broad range of technical issues. Qualified candidates will have strong initiative and the ability to work independently. Our business moves at a rapid pace, making self-motivation and resourcefulness key contributors to success. Flexibility to handle shifts in objectives and timelines is essential.
A degree in engineering with a minimum of five years of work experience in medical device or pharmaceutical manufacturing is required. Strong verbal and written communication skills are required. Must be able to summarize and communicate technical concepts effectively. Must be skilled in analyzing user and process requirements and translating information into functional product design and manufacturing equipment specifications. Must be skilled in testing deployed equipment to confirm proper operation and to verify outputs conform to defined user and process requirements. Must be skilled in troubleshooting mechanical, electrical and software problems, and driving solutions within short timeframes. Must have experience with the FDA QSR, equipment and process validation, and MDD/ISO 13485-related documentation. Experience with cell culture, aseptic handling practices, and operating in clean rooms is preferred.
||3550 General Atomics Court |
San Diego, CA 92121
THIS JOB HAS EXPIRED