Responsibilities
- Responsible for the design, development, and prototyping of mechanical components and consumables used in mechanical sub-systems & complex biotech instruments
- Design and development of automated test fixtures to validate the reliability and robustness of novel components
- Interface with systems & mechanical engineering teams to negotiate designs that meet product requirements & are feasible to manufacture economically
- Conduct design reviews and present fresh ideas, new technologies, and creative solutions to design problems
- Define subsystem architecture
- Show proof of concept through rapid prototyping
- Ability to extract design requirements from a broad spectrum of user needs
- Identify potential design risks and provide a path to derisk/pivot rapidly
- Work closely with the scientific team through the creation of verification /validation protocols (IQ, OQ, PQ) and successful execution, data generation, report and documentation
- Create comprehensive work instructions and manufacturing SOPs as needed for finished designs
Requirements
- BS or MS in Mechanical Engineering, Mechatronics Engineering, or equivalent experience
- 12+ years of extensive, hands-on experience in biotech automation, semiconductor, or similar industries
- Excellent verbal, written, presentation, and interpersonal skills
- Strong analytical and problem-solving skills
- Prior experience with FDA regulations and ISO, cGMP, and QMS standards is a plus
- Knowledge and/or hands-on experience with machine shop tools a plus
- Knowledge of GD&T, as well as strong proficiency with SolidWorks
- Creative, self-motivated, and flexible to work in a small company environment and assume a wide variety of tasks
- Work history with several successful iterations of highly automated instrument design and development (biotech industry experience preferred)
- Desire to be part of a rapidly evolving organization with compelling technology and take products and processes to the next level
- Experience with Python, or high-level scripting software languages, a plus
- Self-awareness, integrity, authenticity, and a growth mindset
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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.
