Manufacturing Engineer

Role Summary

The Manufacturing Process Engineer plays a critical role in supporting the manufacturing of Rani Capsules, providing technical assistance in installation, preventative maintenance, and calibration of equipment, and ensuring process improvements and consistency in manufacturing operations. Works closely with R&D engineering and quality teams to ensure device specifications align with device requirements.

Responsibilities

• Actively support NPI by working hands-on on the production floor to troubleshoot issues, stabilize yields, and drive smooth transitions from development to full-scale manufacturing.
• Collaborate with Development and R&D Engineers to execute effective design transfer, process characterization, and ramp plans.
• Conduct process capability studies and apply DOE, SPC, and data-driven analysis to draw conclusions, implement improvements, and sustain gains.
• Develop standard work, process controls, and monitoring methods to reduce variability across operators, materials, equipment, and workflows.
• Investigate process deviations and failures; perform structured root cause analysis (5-Why, Fishbone, FMEA) and implement robust corrective and preventive actions (CAPA).
• Proactively identify opportunities for improvement and challenge assumptions constructively to drive better outcomes.
• Create and execute IQ/OQ/PQ and related verification and validation protocols, analyze results, and generate complete documentation and reports.
• Ensure compliance with design control, validation, documentation, and change-control policies (FDA, ISO, cGMP, QMS).
• Create and maintain clear, complete manufacturing documentation (MPIs, LHRs, WIs, forms, checklists) that reflect current practices and controls.
• Train and guide technicians and assemblers; drive best practices and foster a culture of safety, quality, and continuous improvement.
• Contribute to design-for-manufacturability (DFM), cost reduction, quality improvement, and automation initiatives.
• Cultivate a mindset of ownership and innovation, where individuals actively seek out challenges and collaborate across teams to solve them.

Qualifications

• 3‚Äì7 years of hands-on experience in a manufacturing environment, with a proven track record in process development, optimization, and validation.
• Extensive experience with process capability studies, FMEA, PPK, GR&R, SPC, and process development/validation.
• Knowledge and experience with plastic injection molding as well as semi-automated and fully automated machines/processes.
• Proven ability to perform statistical data analysis and implement improvement plans using DOE and other methods.
• Strong analytical and problem-solving skills including but not limited to DOE, and statistical data analysis.
• Knowledge of material science and polymer chemistry.
• Diverse background in process characterization and optimization in a manufacturing environment.
• Experience with FDA regulations and ISO, cGMP, and QMS standards.
• Experience with Statistical Software tools such as Minitab or JMP.
• Familiarity with cleaning and sterilization processes.
• Working knowledge of SolidWorks.

Education

• Bachelor‚Äôs Degree in Mechanical, Chemical, Manufacturing, or a related engineering field.
• Relevant certifications as pertains to the position (e.g., Six Sigma, Lean Manufacturing, etc.) is a plus.
• Proficiency in Microsoft Excel, Microsoft Word, and other engineering software tools.
• Familiarity with metrology tools such as CMM, Micro-Vu, SEM, etc. is a plus.

Physical Demands

• The employee is regularly required to stand, walk, and sit for extended periods during the performance of job duties.
• Must be able to physically be present on-site to perform the required tasks.