Senior R&D Engineer (Job Code: 2013-2) ViaCyte
THIS JOB HAS EXPIRED Company Overview: ViaCyte, Inc. is a preclinical therapeutic company focused on diabetes. Our therapy is based on pancreatic beta cell progenitors derived from human pluripotent stem cells. These cells are implanted using 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.
Position Description: The Senior R&D Engineer will contribute to the design and development of a novel cell handling/packaging system, processes, documentation, and validation to meet combination product manufacturing needs as required for a first in human clinical study. Primary responsibilities will include (1) developing cost-effective disposables, processes and prototyping strategies to enable in vitro and in vivo testing of novel designs, (2) integrating established cell culture equipment and techniques with novel designs, tooling and fixtures for cell handling, device loading and packaging, and (3) leading verification and validation efforts for combination product manufacturing systems (including equipment IQ/OQ/PQ) with duties such as establishing requirements and protocols, performing analyses and writing reports. Additional responsibilities include developing SOPs, batch records, CAD models and drawings, and other documentation as required; and generating and reporting scientific data, analyses, and results. Frequent interactions with personnel from other research and manufacturing groups to coordinate product testing will be required. Collaborating with management on critical decisions related to combination product design will be expected.
Our work environment is enjoyable for a team player who also demonstrates 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.
Requirements: A degree in an engineering or related discipline and minimum of five years of work experience in medical device development are required. Strong verbal and written communication skills are required. Must be able to summarize and communicate technical concepts effectively. Must be skilled in identifying complex problems, and proficient in performing independent research under minimal supervision and within short timelines to solve those problems. Must have experience with FDA Quality Systems Regulations, Design Controls, and ISO 13485-related documentation. Experience with cell culture, and cell handling strongly preferred. Experience operating in cleanrooms and with aseptic handling practices is preferred. Experience using CAD for medical device design, including SolidWorks, is preferred.
Application Procedure: Please send your resume or curriculum vitae, with cover letter, to: ViaCyte, Inc., 3550 General Atomics Court, San Diego, California, 92121. Reference Job Code #2013-2 in your correspondence. For submission by e-mail, please attach your resume or CV, with cover letter, as a Word or PDF file. In the Subject line, type the Job Code (#2013-2) and your full name.
||3550 General Atomics Court |
San Diego, CA 92121
THIS JOB HAS EXPIRED