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Job Descrption

Position Summary
We are seeking an innovative and highly motivated Staff Manufacturing Engineer, who will contribute significantly to the manufacturing of equipment used to produce cell therapy solutions. This position will report to the Director of Engineering.
The primary focus of this position will be to drive the manufacturing effort at our Contract Manufacturer and act as a liaison between our internal Engineering team and the CM. As a Staff Manufacturing Engineer, you will take ownership of a wide range of tasks pertaining to the fabrication, assembly and test of multiple subsystems. During this process, you will be required to provide schedule updates, mitigation plans, assist CM with troubleshooting and end of line testing.  
This is a multidisciplinary role & this individual will interface across many parts of the company (engineers, installers, field service) to ensure the manufacturability and scalability of the best solutions possible. The successful candidate will be experienced in the areas of mechanical design, 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 overseeing manufacturing activities at Contract Manufacturer
• Work closely with CM to solve any technical or supplier issues
• Drive End of Line (EOL) acceptance testing criteria  
• Assist in troubleshooting technical issues at CM and in the field
• Develop, document, and follow standard operating procedures and work instructions
• Develop and manage manufacturing documentation framework/templates
• Investigate nonconformances and deviations at component and subsystem level  Initiate and process engineering, document, and ERP system changes
• Collaborate with design engineers on early-stage hardware development with a focus on manufacturability, process capability, design scalability, and total cost
• Review engineering drawings to ensure drawing definition is optimized for manufacturability
• Generate complete documentation packets and transfer products to contract manufacturers

Requirements

• BS or MS in Mechanical Engineering, Mechatronics Engineering, or equivalent experience10-15 years of extensive, hands-on experience in biotech automation, semiconductor or similar industries
• Work history with several successful transfers of highly automated equipment to CM
•  Excellent verbal, written, presentation and interpersonal skills
• Strong analytical and problem-solving skills
• Experience with a wide variety of manufacturing techniques including hands on experience with machine shop equipment
•  Prior experience with FDA regulations and ISO, cGMP, QMS standards is a plus
• Knowledge of GD&T as well as proficiency with SolidWorks
• Creative, self-motivated, 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.

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