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.
The Manager of Device Engineering plans, directs, and manages implementation of the design, development, and transfer to manufacturing of one or more new medical device or combination products. This may require direct contribution, oversight of reports or a project team, and/or project management of the product development and manufacturing process. This role also provides engineering support for existing products.
This is a full-time position located in San Diego, CA.
Essential Duties & Responsibilities:
- Manage product development of one or more medical devices integrated with cell therapies, delivery tools, related delivery systems and packaging, resulting in novel combination products for treatment of major unmet medical needs.
- Technically lead device-based process development projects focused on scaling, yield efficiency and/or cost reduction. Identify opportunities and champion execution and analysis of realized outcomes. Manage training and tech transfer to manufacturing team.
- Identify and implement engineering sustaining projects intended to improve clinical and commercial products. Evaluate design opportunities to improve ease of use and/or performance of device, packaging and procedural method. Maintain awareness of user feedback on device and procedure through clinical attendance and customer engagement.
- Ensure compliance with ViaCyte’s Quality Management System by managing and implementing the design control process for new or existing medical devices and combination products that incorporate one or more medical devices, including requirements definition, design planning, verification and validation activities, FMEA development, etc.
- Provide leadership and direction to an engineering team to accomplish all team goals and objectives. Develop team by assigning goals and projects that challenge and advance technical and leadership abilities of members. Foster environment of accountability and effective communication. Provide one-on-one mentorship to team members.
- Conduct project management for assigned products/projects. Create cross functional project schedules within the Device and Combination Product programs through to clinical release. Assign owners of activities and track activities on weekly basis. Establish and assure adherence to budgets, schedules, work plans, and performance requirements.
- Guide the conceptualization of new methodologies, materials, equipment, processes or products related to the company’s proprietary medical device and combination product technologies. Work with legal and engineering teams to generate and protect new intellectual property as appropriate.
- People management responsibilities including hiring / terminations, performance reviews, and career development coaching.
- Review and approval of SOP’s, verification studies, batch records, raw material specifications, drawings and other documentation as required for device or combination product.
- Maintain expertise in current industry technologies focused on micro and macro encapsulation of cell products. Generate and present scientific data, including scientific papers and research reports.
- B.S., M.S., or PhD in biomedical, mechanical, chemical, materials engineering, or related field is required. Minimum of eight years of applicable 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.
- Prior experience leading R&D engineering teams in collaborative, dynamic environments. Minimum 2 years of people management.
- Demonstrated experience working in medical device manufacturing (clean room) environment
- Demonstrated experience developing and implementing medical device design controls, preferably for implantable devices
- Demonstrated experience with FDA Quality System Regulations and ISO 13485
- Experience writing, reviewing and implementing equipment validations (IQ/OQ/PQ)
- Demonstrated experience developing and executing verification and validation testing for medical device
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.