Responsibilities
- Own the overall technical execution of the transfer, coordinating across engineering, manufacturing, supply chain, and quality teams
- Own and contribute to the mechanical design of system components and assemblies, ensuring performance, reliability, and manufacturability
- Review and update CAD models and drawings as needed to support the transfer and production ramp
- Collaborate with cross-functional teams to resolve design issues and implement improvements based on feedback from testing and manufacturing
- Prepare, review, and release Bills of Materials (BOMs) and engineering drawings in accordance with company standards
- Drive the creation and processing of Engineering Change Orders (ECOs) to support product updates and CM readiness
- Define and implement test methods and inspection criteria at the CM to ensure product quality and reliability
- Establish and track build schedules, milestones, and shipment timelines at the CM
- Provide on-site or remote technical support to CM during prototype, pre-production, and production builds
- Serve as the primary technical liaison between internal teams and external partners (including the CM)
- Interface with internal disciplines (electrical, systems, quality, supply chain, etc.) to ensure product requirements and design intent are preserved
Requirements
- Bachelor’s degree in Mechanical Engineering or a combination of technical education and experience
- 15+ years of hands-on experience in Mechanical engineering with significant exposure to product development, manufacturing, and CM transfer
- Proven experience managing the technical aspects of system-level builds and CM onboarding
- Strong experience in CAD, PLM systems, BOM management, and ECO processes
- Hands-on experience developing and implementing test methods
- Ability to operate autonomously in a dynamic, cross-functional environment
- Previous experience working with domestic and international CM’s is highly desirable
Top Skills
What We Do
Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit.
The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope.
Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale.
Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need.
The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.
