Manufacturing Engineer II

Rapidmicrobio; Lowell (MA); On-site; USD 100,000 - 110,000; Full time

Job summary

Rapid Micro Biosystems in Lowell, MA is seeking a Manufacturing Engineer II to support the day-to-day operation of automated production equipment in an ISO 8 cleanroom. You will work with engineers to optimize yield and equipment uptime.

The role requires troubleshooting automation, documenting procedures, and maintaining compliance with cGMP, 21 CFR Part 11, and ISO 13485. In-person work in Lowell is expected and safety protocols apply.

Qualifications

• Bachelor’s or Master’s degree in Electrical Engineering, Automation, Mechatronics, or related field.
• 2+ years of manufacturing engineering experience in medical devices or regulated industry.
• Experience with AutoCAD and 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, ISO 13485).
• Experience with PLC programming and SCADA systems.
• Knowledge of FDA regulations, ISO 13485 and 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, FAT, SAT, and equipment validation activities.
• Develop and maintain technical documentation, including electrical schematics, CAD drawings, control logic diagram, SOPs, 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.

Education

Bachelor’s or Master’s degree in Electrical Engineering, Automation, Mechatronics, or related field

Tools

AutoCAD

SolidWorks

PLC programming

SCADA systems

HMI design tools

Robotic systems

Job description

Manufacturing Engineer II

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.

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.

Qualifications

• 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).
• 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.

Work Conditions

• This is not a remote or hybrid-remote position, in-person attendance is expected.
• Will be required to work in a cleanroom environment for extended periods.
• Appropriate gowning procedures will be required for access to cleanroom (hairnet, safety glasses, cleanroom apparel/lab coats, gloves).
• Occasional environmental odors may be present.
• Occasional off‑shift or weekend work may be required to support production.

Compensation

Rapid Micro Biosystems is proud to offer a competitive total compensation package designed to attract, inspire and retain the best talent in our industry. In addition to base pay, our full‑time regular employees are eligible for an attractive benefits package, cash incentive opportunities, and an equity grant.

The base annual salary hiring range for this position is $100,000-110,000.

Starting salaries are determined based on skills, experience, budget and other job‑related factors. More information about our total compensation package will be shared with candidates during the recruitment process.

Equal Opportunity

Rapid Micro Biosystems is committed to the principle of equal employment opportunity. Applicants for employment and employees are reviewed on their individual qualifications for a position. Under no circumstances will Rapid Micro Biosystems discriminate against qualified persons on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender identity, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law.