Manufacturing Engineer (I, II, III)

Cellares; South San Francisco (CA); On-site; USD 90,000 - 210,000; Full time

Job summary

An innovative firm is seeking a talented Manufacturing Engineer to enhance product quality and operational performance. This role involves investigating quality defects, implementing effective countermeasures, and ensuring compliance with regulatory standards. You will collaborate with cross-functional teams to drive continuous improvement in manufacturing processes and maintain high-quality standards. If you thrive in a fast-paced environment and are passionate about quality engineering, this is the ideal opportunity for you to make a significant impact in the medical device industry.

Benefits

Medical, Dental, and Vision Plans

401(k) Matching

Free EV Charging

Onsite lunches

Stock options

Qualifications

• 5 years of experience in manufacturing or quality engineering.
• Proven ability to perform root cause analysis and develop countermeasures.

Responsibilities

• Lead investigations to determine root causes of quality defects.
• Perform incoming inspections on consumable assemblies.

Skills

Root Cause Analysis

Quality Engineering

Problem-Solving Techniques

Attention to Detail

Communication Skills

Education

Bachelor's degree in Engineering

Advanced degree (preferred)

Tools

FMEA

ISO 13485 Standards

Job description

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Join to apply for the Manufacturing Engineer (I, II, III) role at Cellares

We are seeking a talented and driven Manufacturing Engineer to join our team and take ownership of root cause analysis, implement countermeasures for quality defects, and perform incoming inspections on parts for consumables produced by ISO-13485-regulated contract manufacturers.

The primary focus of this position will be investigating quality defects, identifying root causes, and implementing effective countermeasures to prevent recurrence. You will also perform incoming inspections on parts and materials, ensuring they meet quality and regulatory standards before they enter production. This role is vital to maintaining the integrity of our products and ensuring that manufacturing operations run smoothly and efficiently. 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

• Lead investigations to determine the root cause of quality defects or production issues using structured problem-solving techniques (e.g., 5 Whys, Fishbone diagram, and proactively utilizing Failure Mode and Effect Analysis - FMEA)
• Develop and implement robust countermeasures for identified quality issues to prevent future defects
• Collaborate with cross-functional teams to ensure solutions are effective and sustainable
• Perfom detailed incoming inspections on consumable assemblies to verify they meet performance specifications
• Drive continuous improvement efforts to enhance product quality, manufacturing efficiency, and overall operational performance at global contract manufacturers. Lead initiatives to reduce defects and improve yield
• Maintaindetailed records of quality investigations, root cause analysis, corrective actions, and inspection results. Prepare and present reports on quality performance to management and other stakeholders
• Provide training and guidance to production teams on quality standards, best practices, and defect prevention techniques.
• Support production teams in troubleshooting quality issues during manufacturing runs
• Work closely with design, engineering, and production teams to ensure manufacturability and quality of new products. Collaborate with vendors and suppliers to address quality concerns related to incoming materials
• Create and maintain BOMs, standard operating procedures (SOPs), work instructions, and other documentation to ensure consistency and regulatory compliance
• Support the introduction of new products into manufacturing, including pilot runs, scale-up processes, and transfer to full-scale production
• Collaborate with CMs and Factory Engineering team to ramp new manufacturing production lines and equipment to targets to meet business needs, analyze yield and OEE issues to identify areas and opportunity for continuous improvement and implement resolutions
• Support manufacturing lines and key processes at suppliers, contract manufacturers, and internal manufacturing
• Review and approve supplier process controls, and be responsible for reviewing and approving engineering change orders
• Create Requirements and Qualification plans for automated testing equipment located at contract manufacturers.
  
  

Requirements

• Bachelor's degree in Engineering, Science, or a relevant field. An advanced degree is preferred.
• 5 years of experience in a manufacturing or quality engineering role, preferably within the medical device or consumables industry
• Proven ability to perform root cause analysis and develop effective countermeasures to resolve quality issues
• Strong attention to detail with the ability to identify defects and inconsistencies, ensuring products meet required specifications
• Excellent communication skills, both written and verbal, with the ability to clearly document findings, present solutions, and collaborate with cross-functional teams
• Ability to work effectively with teams across different functions, including contract manufacturers, quality assurance, engineering, and supply chain
• Flexibility to travel up to 20% of the time, including international travel, to support company projects and initiatives.
  
  

Preferred Skills/Experience

• Experience with regulatory standards such as ISO 13485 and/or FDA 21 CFR Part 820
• Knowledge of medical device or consumable manufacturing processes (e.g., injection molding, assembly, sterilization)
  
  

$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.

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Pharmaceutical Manufacturing

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