Manufacturing Engineer II
Team: MFG Engineering - 1060
Location: Lowell, MA
Commitment: FTE Exempt - REG
Workplace Type: onsite
ESSENTIAL JOB FUNCTIONS
- 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.
EDUCATION & EXPERIENCE
- 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.
REQUIRED TECHNICAL SKILLS
- Experience in PLC programming (Allen-Bradley, Siemens, etc.).
- 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).
PREFERRED QUALIFICATIONS
- Experience in AutoCAD, SolidWorks for mechanical adjustments.
- 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.
WORKING 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.
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,OOO-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.
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