Manufacturing Engineer

Rani Therapeutics, LLC; Fremont (CA); On-site; USD 120,000 - 165,000; Full time

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.

Skills

Process development

DOE

SPC

CAPA

Root cause analysis

Data analysis

Manufacturing

Education

Bachelor’s Degree in Mechanical/ Chemical/ Manufacturing or related engineering field

Tools

Minitab

JMP

SolidWorks

Excel

Job description

There has never been a more exciting time to join Rani Therapeutics. With the successful completion of 3 Phase 1 studies and the advancement of the RaniPill® platform, we are making meaningful progress toward our goal of transforming how biologics are delivered—bringing us closer to improving the lives of millions of patients worldwide. As we continue to grow and innovate, we are looking for talented, driven individuals to join our team and be part of what is next.

At the heart of our culture are the values that bring us together and move us forward. While we share common goals, we know it is our different perspectives and experiences that make us better. We are committed to creating a workplace where people feel respected, supported, and valued—and where everyone has the opportunity to grow and contribute. These values reflect how we work, connect, and succeed as a team.

Relentlessness

We go after results with energy and ownership.

• We stay focused on outcomes, not obstacles
• We push through challenges instead of backing down
• We find our own motivation and bring it every day
• We take smart risks and are not afraid to fail

We succeed together, not alone.

• We trust and support one another
• Every voice matters, and we make space to hear it
• We step in to help without being asked
• We respect the experience and expertise of others

We communicate honestly and welcome new ideas.

• We listen actively and without bias
• We encourage creativity and fresh thinking
• We value diverse perspectives and contributions
• We communicate clearly, consistently, and often

Integrity

We do the right thing—always.

• We hold ourselves to high ethical standards
• We follow through on our commitments
• We align our actions with our words
• We protect and strengthen our brand in everything we do

We stay ahead and take ownership.

• We plan with intention and purpose
• We address issues early, before they grow
• We continuously look for ways to improve and work smarter
• We take initiative and act without waiting to be asked

Designed to help you thrive

We know that doing great work also means having the support, balance, and resources to thrive. Our benefits and perks are designed to promote well-being, encourage connection, and support both personal and professional growth. From comprehensive health coverage to opportunities to recharge, connect, and develop, we aim to create an environment where our people can thrive.

• Medical, Dental, and Vision coverage
• Life Insurance / LTD / STD
• 401(k) Retirement Plan
• 13 Scheduled Paid Holidays
• Paid Time Off (PTO) starting at 3 weeks
• Sick Time
• Wellness Works Program
• Career Development & Learning Opportunities
• Team Events & Social Gatherings

Hiring Process

What you can expect

Our hiring process is designed to be thoughtful, transparent, and engaging. Throughout, we make time for your questions so you can feel confident this is the right fit for you, too.

• 1 Phone Screening: A conversation to learn about your experience and interests, and for you to learn about us.
• 2 Interviews: One or more interviews, virtual or in person, with team members you would be working closely with.
• 3 Getting to Know Each Other: Time for your questions—our team, our culture, and how you can make an impact.

Open Positions

We are actively hiring

If you think you have the right experience and would like to be part of a dynamic team, we want to hear from you.

Position:Manufacturing Engineer

Location: Fremont, CA

Job Id:105

# of Openings:1

MANUFACTURING ENGINEER

General Information

Position Title: Manufacturing Engineer

Department: Manufacturing

Reports to: Senior Manager, Manufacturing

Position Overview

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

Key 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

Experience

• 3–7 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’s 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.

Join a team that is changing the way the world delivers medicine.