Senior/Staff Engineer, R&D

ViaCyte is a leading regenerative medicine company harnessing the latest innovations in science, engineering and regenerative medicine to develop functional cures for chronic diseases.  Our proprietary stem cell-based therapy approach has possible application across multiple disease states that can potentially be treated by replacing lost or malfunctioning cells or proteins.  The dedicated team at ViaCyte is initially focused on treating Type 1 diabetes with a proprietary platform designed to differentiate stem cells into cells that function like a pancreas by automatically controlling blood glucose levels.  

Backed by two decades of research and expertise, we are the first to advance this approach into human clinical trials and show therapeutic effect in patients with the most advanced cell replacement portfolio for Type 1 diabetes.  Through partnerships with two world class leaders, CRISPR Therapeutics and W L. Gore & Associates, we are optimizing our cells and therapeutic delivery to create cell replacement therapies for diabetes that do not require immunosuppression and represent a functional cure.  With collaboration and patient focus driving our work, our mission is to reduce the relentless burden of disease management, improve health outcomes, and enhance quality of life for people living with chronic diseases.

ViaCyte is headquartered in San Diego, California. For more information, please visit www.viacyte.com and connect with ViaCyte on Twitter, Facebook, and LinkedIn.

Position Description:

Combine research methods and engineering techniques to design and develop novel implantable devices and combination products. Serve as technical lead and project manager for assigned projects. Incumbent shall also contribute to the development of manufacturing methods and processes and champion system validations for novel loading/packaging systems in support of ongoing preclinical and clinical studies.

This is a full-time position located in San Diego, CA.

Essential Duties & Responsibilities:

  • Technically lead product development of novel combination products and their related delivery systems and packaging. Support development activities such as defining voice-of-customer, proof-of-concept, verification/validation testing and tech transfer through to successful product launch.
  • Support clinical engineering and user training as needed.
  • Maintain expertise regarding materials, biologics and implantable technologies in the cell therapy space. Identify and advocate product research opportunities via internal pre-clinical evaluation and/or external collaborations.
  • Champion combination product and cell therapy process development to identify end-to-end solutions. Identify scaling/ optimization opportunities, establish user requirements and implement solutions to address technical challenges in the manufacturing process to support short- and long-term manufacturing needs
  • Support project management activities related to design, development and manufacture of medical devices and combination products from
  • Concept/Feasibility to Clinical Release. Provide communication of project milestones and overall tracking to Sr. Management and cross functional groups.
  • Define and implement verification and validation strategies of combination products and packaging systems. Lead development of establishing requirements, writing protocols, performing R&D and clinical data analyses and writing reports. Collaborate with cross functional groups to ensure timely completion of DHF elements.
  • Design and develop packaging systems and supporting materials, including disposables, tooling & fixtures and processing equipment for the medical device and combination product programs. Generate intellectual property as appropriate.
  • Serve as Engineering lead for in vivo studies related to development of the cell product, implantable medical device, and combination product.
  • Interact with scientific personnel from other research and manufacturing groups to coordinate objectives and execution.
  • Identify and establish projects within Product Development, Manufacturing, R&D, and Quality departments that improve efficiency or add measurable value to organization.
  • Develop cost effective prototyping strategies to enable in vitro and in vivo testing of novel designs.
  • Develop SOP’s, batch records, raw material specifications, drawings and other documentation as required for combination product and cell manufacturing. Lead technology transfer of design outputs to manufacturing.
  • Generate and present scientific data, including scientific literature and research reports.

Required Qualifications:

  • B.S., M.S., or PhD in biomedical, mechanical, chemical, materials engineering, or related field is required. Minimum of five years of work experience in medical device, combination product, and/or cell therapy development.
  • An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable
  • Title will be determined based on experience

Skills/Knowledge/Abilities:

  • Must be skilled in Microsoft Office, including Word, Excel and PowerPoint.
  • Strong verbal and written communication skills are required. Must be able to summarize and communicate technical concepts effectively.
  • Must be skilled in identifying complex scientific problems and experimental hurdles, and in solving those problems.
  • Must be proficient in performing independent research under minimal supervision and within short timelines.
  • Experience with project management concepts and fundamentals
  • Must have experience with FDA Quality Systems Regulations, Design Controls, and ISO 13485-related documentation preparation.
  • Experience with cell culture, tissue culture, and cell handling strongly preferred.
  • Strong theoretical knowledge of materials and mechanics preferred.
  • Experience operating in clean rooms, aseptic handling practices preferred.
  • Advanced experience using CAD, SolidWorks preferred.

ViaCyte is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer (EEO). All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. 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.

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