Staff NPI Engineer
San Francisco, CA, USA
Posted on Friday, May 12, 2023
We are seeking an innovative and highly motivated Staff NPI Engineer, who will contribute significantly to the development of cell therapy solutions. This position will report directly to the Supervising Staff NPI Engineer.
The primary focus of this position will be to develop, test, and assemble critical engineering subsystems. As an Staff NPI Engineer, you will take ownership of a wide range of tasks pertaining to high value internal projects - from assisting in bring-up and testing of finished assemblies, designing test fixtures, troubleshooting, to documentation and contract manufacturer interfacing. 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 & this individual will interface across many parts of the company (with scientists, researchers, and engineers) 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.
- Develop, document, and follow standard operating procedures and work instructions
- Develop and manage manufacturing documentation framework/templates
- Play a major role in facilitating CMs to ramp up production
- Work closely with CM to source suppliers for components
- Develop fixtures for testing and manufacturing
- Investigate nonconformances, deviations, and customer complaints
- Determine impact to product performance, functionality, and customer use/safety
- Initiate and process engineering, document, and ERP system changes
- Draft protocols, conduct studies, and create reports for validation activities
- Assist in troubleshooting technical issues
- Work with design engineers, procurement specialists, and external vendors to ensure requirement flowdowns result in the appropriate selection of manufacturing processes, tooling, and inspection techniques
- Collaborate with design engineers and analysts 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
- BS or MS in Mechanical Engineering, Mechatronics Engineering, or equivalent experience
- 5-10 years of extensive, hands-on experience in the semiconductor, biotech automation, or similar industries
- Excellent verbal, written, presentation and interpersonal skills
- Strong analytical and problem-solving skills
- Prior experience with FDA regulations and ISO, cGMP, 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
- Experience with a wide variety of manufacturing techniques
- Creative, self-motivated, 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 (non-biotech industry experience is OK)
- 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 creating the future of cell therapy manufacturing. The company is developing an innovative cell therapy manufacturing solution that is robust, cost-effective and scalable so that cell therapies are more affordable and widely available to patients in need. Our multidisciplinary team comes together from diverse backgrounds with a shared passion for accelerating access to life-saving cell therapies. We value integrity, curiosity, the courage to grow and embrace change. At Cellares, you will collaborate with a world class team of engineers, scientists, and business leaders who are as excited about improving the world as you are.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
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