Staff Manufacturing Engineer
South San Francisco, CA
Engineering - Development – Manufacturing Engineering /
Full Time /
On-site
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
$90,000 - $210,000 a year
Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.
