Manufacturing Engineer, Biotech NPI & Process Excellence

Rani Therapeutics, LLC

Fremont (CA)

On-site

USD 120,000 - 165,000

Full time

14 days+

Get more replies from employers

Send a job-specific resume in minutes.

Job summary

Rani Therapeutics, LLC in Fremont, CA is seeking a Manufacturing Engineer to support the production of Rani Capsules on-site. The role focuses on installation, preventive maintenance, calibration, and process improvements to ensure device manufacturing meets stringent specifications.

The ideal candidate will bring 3–7 years of manufacturing experience, strong skills in DOE/SPC/FMEA, and a collaborative mindset to work with R&D, quality, and manufacturing teams on continuous improvement and

Qualifications

3–7 years of hands-on experience in a manufacturing environment.
Experience with process capability studies, FMEA, PPK, GR&R, SPC, and process development/validation.
Knowledge of plastics injection molding and automated processes is preferred.
Strong analytical and problem-solving skills with data-driven approaches.

Responsibilities

Support NPIs by hands-on troubleshooting on the production floor to stabilize yields.
Collaborate with Development and R&D to execute design transfer and ramp plans.
Conduct DOE and data-driven analysis to drive improvements and sustain gains.
Create standard work, controls, and monitoring to reduce variability across operations.
Investigate deviations; perform root cause analysis and implement CAPA actions.
Develop IQ/OQ/PQ protocols and maintain verification documentation.
Ensure compliance with FDA, ISO, cGMP, and QMS specifications.