Manufacturing Engineer II

Rapid Micro BiosystemsLowell, MA
Onsite

About The Position

Winning the race to bring new healthcare products safely to a waiting world drives Rapid Micro Biosystems (RMB) to combine today’s innovative technologies as never before. Your career at RMB puts you at the center of diverse global teams that span robotics, AI, Machine Learning, imaging, microbiology, and more, re-shaping how urgently needed pharmaceuticals are made, tested, and released for decades to come. The sky’s the limit. Careers at RMB are fast-moving, with the high growth you’d expect from a world leader in microbiology automation. Advancement at RMB affords an opportunity to achieve your personal goals and develop your passions, in an inclusive environment where every employee has the resources and opportunities to hone their skills. You’ll do more, learn more, and have the ability to make a profound impact on our business. The Manufacturing Engineer II will have responsibility to support the day-to-day operation of automated production equipment at RMB, Lowell. This position requires mechanical skills and must be able to work in an ISO 8 cleanroom. This individual will work closely with other engineers in the team to optimize Yield and Uptime for our production equipment.

Requirements

  • Bachelor’s or Master’s degree in Electrical Engineering, Automation, Mechatronics, or a related field.
  • 2+ years of manufacturing engineering experience, preferably in the medical device or regulated industry.
  • Experience in AutoCAD, SolidWorks for mechanical adjustments.
  • Experience in machine integration, mechanical design modifications, and troubleshooting.
  • Familiarity with cGMP and validation practices (IQ/OQ/PQ under 21 CFR Part 11, and ISO 13485).

Nice To Haves

  • Experience in PLC programming (Allen-Bradley, Siemens, etc.).
  • Experience in SCADA systems (e.g., FactoryTalk suite, Ignition).
  • Experience with robotic systems or automated inspection platforms.
  • Knowledge of FDA regulations, ISO 13485.
  • Knowledge of HMI design tools.

Responsibilities

  • Lead initiatives to reduce equipment downtime and increase yield.
  • Troubleshoot automation systems and provide root cause analysis for equipment downtime, yield loss, and process variation.
  • Lead and support commissioning, factory acceptance testing (FAT), site acceptance testing (SAT), and equipment validation activities.
  • Develop and maintain technical documentation, including electrical schematics, CAD drawings, control logic diagram, standard operating procedures, and maintenance guides.
  • Train manufacturing and maintenance personnel on automated equipment operation and basic troubleshooting.
  • Ensure compliance with safety standards, regulatory requirements, and internal manufacturing and quality systems.
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