Develop and refine system requirements while leading projects in cell therapy systems design. Mentor team members and ensure streamlined project development by integrating customer requirements with technical specifications.
Cellares is seeking an innovative and highly motivated Staff Systems Engineer who will contribute significantly to the development of cell therapy systems that have never been realized before.
The primary focus of this role is to apply a systems-thinking approach and techniques to design and develop a first-in-its-class instrument, collaborating with cross-functional teams of engineers and scientists. As a Staff Systems Engineer, you will take ownership of a wide range of tasks of high-value internal projects from requirements capture and architecture development, system prototyping and integration, to verification and validation activities. During this process, you will be required to provide in-depth analysis and help guide important decisions during design reviews and architecture discussions.
This is a multidisciplinary role, and you will interface across many parts of the company (with scientists, researchers, and other engineers) to develop the best solutions possible. The successful candidate will be a resident expert in the areas of systems engineering, fluidic control, and highly automated instrument development. This is a hands-on position.
Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows
Responsibilities
- Responsible for developing, maintaining, and refining system requirements and architecture
- Create and maintain documents, models & diagrams describing functional and physical decompositions, interface definitions, and flow diagrams
- Responsible for developing, maintaining, and executing system and subsystem design verification protocols
- Lead small project teams developing Cellares technology or testing strategies
- Mentor junior members of the Systems Engineering team on best engineering practices
- Support architecture definition by working with subsystem design teams to align overlapping design requirements, constraints, and drive teams in developing concepts, evaluating risks, and efficiently converging on a design path
- Translate architectural concepts into prototypes, integrate them, analyze results, and iterate on the design
- Work closely with product management to interpret customer, business, and compliance needs to define technical requirements
- Develop system models that guide design decisions. These can include system tolerance budgets, performance models, COGS models, etc
- Provide support to sub-system engineers in the development of models that guide lower-level design decisions
- Develop test systems for internal use to support both R&D experiments and pilot build testing needs
- Conduct design reviews and present fresh ideas, new technologies, and creative solutions to design problems
- Using a structured approach for problem solving, lead teams through complex root-cause analysis in which there are many possible root causes that involve various areas of physics and engineering
Requirements
- Bachelor's, Master's, or PhD in Physics or Engineering with 10+ years of extensive and hands-on experience in the development of analytical instrumentation, biotech automation, or similar is required
- Hands-on experience designing and integrating in the lab highly complex instrumentation prototypes that combine fluidic handling, electronic sensors, or robotics
- Specific expertise in bioprocessing technologies involved in cell therapy manufacturing is highly desired
- Working knowledge of requirements and risk management tools like JamaConnect, IBM Doors, TeamCenter, Orcanos, or Helix
- Experience with MATLAB, Python, or high-level scripting software languages for modeling, simulation, and data processing
- Working knowledge of Statistical Design of Experiments, Data Analysis and Visualization, with SW tools such as JMP, Minitab, and Tableau
- Excellent verbal, written, presentation, and interpersonal skills
- Strong analytical and problem-solving skills
- Demonstrated track record of rapidly climbing steep learning curves
- Prior experience working in ISO regulated environments (ISO 13485, ISO 14791)
- Creative, self-motivated, and flexible to work in a small company environment and assume a wide variety of tasks
- Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level
- Self-awareness, integrity, authenticity, and a growth mindset
This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
Top Skills
Helix
Ibm Doors
Jamaconnect
Jmp
Matlab
Minitab
Orcanos
Python
Tableau
Teamcenter
Cellares South San Francisco, California, USA Office
345 Allerton Ave, South San Francisco, CA, United States, 94080
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