ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices. Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels. ViaCyte has two product candidates in clinical-stage development. The PEC-Direct™ product candidate (also known as VC-02) delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes. The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin. ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications. ViaCyte is headquartered in San Diego, California. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.
As a member of the Engineering team, the engineer shall support product development, process development, and manufacturing activities. The employee shall utilize R&D methods and engineering techniques to design and develop new devices and combination products, develop processes, generate test systems, and improve manufacturing procedures. Engineer shall also support the development of new surgical procedures, write and execute engineering protocols, and document reports, and all elements necessary to launch products through design control.
1. Product Development: Conceive, design, develop, test, and refine cost-effective device or combination product prototypes to enable in vitro and in vivo testing. This includes supporting the development of new surgical procedures. Conduct studies to demonstrate the feasibility of a product concept. Define product requirements and specifications. Develop processes necessary to fabricate devices or combination products. Develop and implement test methods for assessing the quality of in-process and finished products. Develop, execute, and analyze design verification and validation studies, culminating in a design history file.
2. Project Management / Leadership: Lead projects of small to moderate scope as a project manager. May coordinate activities of other junior personnel. Work with other Engineering and cross-functional employees to achieve company and department milestones on time and on budget. Maintain flexibility in a highly dynamic, cross-functional environment working with highly dedicated cross-functional colleagues in a culture focused on continuous improvement.
3. Manufacturing Support: Identify and implement improvements to manufacturing processes and process flow. Develop fixturing or other tools necessary for efficient manufacturing operations. Conduct equipment preventative maintenance or qualification studies as necessary. Conduct preclinical build operations as necessary. Initiate and define process validation activities.
4. Quality Support: Write, amend, and review SOP’s, batch records, raw material specifications, drawings, and other documentation as required to support product manufacturing and quality control testing. Identify and drive resolution of non-conforming material (NCMRs) or corrective actions (CAPAs).
5. Clinical Support: Attend clinical procedures, document findings, synthesize, and drive advancements in clinical procedures necessary to achieve safety and efficacy targets.
6. Engineering / Scientific Acumen: Generate and present scientific data, including scientific papers and research reports. Work cross-functionally with scientists to generate preclinical study concepts, and work collaboratively to conduct study and report out results.
1. Strong verbal and written communication skills are required. Must be able to summarize and communicate technical concepts effectively.
2. Must be skilled in identifying complex scientific problems and experimental hurdles, and in solving those problems.
3. Class II or III medical device or combination product experience required.
4. Must be proficient in performing independent research under minimal supervision and within short timelines.
5. Experience with statistics, experimental design, and data analysis fundamentals
6. Must have experience with FDA Quality Systems Regulations, Design Controls, and ISO 13485-related documentation preparation.
7. Experience with cell culture, tissue culture, and cell handling strongly preferred.
8. Strong theoretical knowledge of materials and mechanics preferred.
9. Experience operating in clean rooms, aseptic handling practices preferred.
10. Advanced experience using CAD, SolidWorks preferred.
B.S., M.S., or Ph.D. in chemical, mechanical, biomedical engineering, or related field is required. Minimum of five years of work experience in medical device development.
An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.
For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2020-12 and your full name. Send to email@example.com. Our mailing address: ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.
It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.
ViaCyte’s goal is to increase representation of women, people of color, veterans, and individuals with disabilities. Our programs are designed to comply with all applicable federal, state, and local laws, directives, and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions, and social/recreational programs.