Sr. Automation Engineer

Rani Therapeutics-posted 9 days ago
Full-time • Mid Level
Fremont, CA
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We are seeking a Sr. Mechanical Automation Engineer to design, develop, and validate semi or fully automated equipment that is used for the scale-up of high volume, platform delivery devices. The Senior Automation Engineer is responsible for designing, implementing, and sustaining high‑reliability automated systems for drug–device combination product manufacturing. The role owns line‑level automation performance, from PLC/motion and vision through high‑volume scale‑up, and partners closely with Mechanical Design, Tech Transfer, and Validation to deliver robust, compliant commercial operations. This is a hands-on position that requires interaction and collaboration with a cross-functional team including Engineering, Manufacturing, Biology, Quality, Facilities, and Sustaining.

  • Develop and improve tooling, including semi-automation.
  • Assess and enhance manufacturing processes by applying engineering concepts and operator feedback.
  • Lead design ownership, URS creation, concept reviews, proof of concept, stakeholder coordination, verification/validation, launch, and documentation.
  • Draft detailed work instructions and SOPs.
  • Support or lead engineering runs and scale-up from pilot to commercial automation.
  • Convert development parameters and URS into automated control recipes.
  • Participate in dFMEA/pFMEA, define CPPs/CQAs, and propose control strategies and alarm limits.
  • Create and execute verification/validation protocols (IQ/OQ/PQ), collect data, and complete documentation.
  • Manage relationships and work with vendors, machine shops, and contract manufacturers.
  • Adhere to company policies for design control, validation, and documentation.
  • Facilitate regular meetings and communication channels to promote collaboration and alignment across teams.
  • Coordinate with cross-functional teams including engineers, consultants, and external partners to ensure project objectives are met on time and within budget.
  • Develop team members by providing necessary guidance, identifying necessary training, and providing professional development activities to build competence and depth
  • Develop detailed project plans outlining timelines, milestones, resource requirements, and deliverables while maintaining good design control practices.
  • Bachelor's Degree in Mechanical Engineering
  • 5 - 10 years hands-on, relevant experience.
  • In-depth experience with complex mechanical/electromechanical design.
  • Extensive experience with precision mechanisms, pneumatics, servo systems, tooling/fixtures, and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
  • Experience with creating engineering drawings, BOMs and product specifications.
  • Deep knowledge of material properties, heat treatment, and surface finish.
  • Proven track record with Medical Device Manufacturing Methods/Procedures, FDA regulations, ISO, cGMP, and QMS standards.
  • Integration with SCADA/MES and basic industrial networking (Ethernet/IP or PROFINET), including good practices for segmentation and security in a GMP setting.
  • Good understanding of DFM and lean manufacturing.
  • Excellent verbal, written, presentation and interpersonal skills.
  • Strong analytical and problem-solving skills.
  • Knowledge and/or hands-on experience with machine shop tools.
  • Deep knowledge of GD&T as well as proficiency with SolidWorks.
  • Creative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasks.
  • Demonstrated experience with high-speed automated lines in medical device, biotech, or pharmaceutical manufacturing.
  • Practical experience specifying and commissioning machine vision for precision parts inspection (e.g., Cognex, Keyence).
  • Expertise in PLC/motion programming (e.g., Rockwell/Siemens), structured text, ladder logic, and modular code.
  • Experience with servo drives, electronic gearing, camming, and PID tuning.
  • Knowledge of PackML/state-based control and ISA 101 HMI design.
  • Master’s degree in Mechanical Engineering or equivalent.
  • Knowledge/experience with plastic injection molding.
  • Knowledge/experience with DOE, SPC, JMP /Minitab.
  • Experience with metal stamping, laser cutting and chemical etching.
  • Familiarity with and sterilization process and aseptic environment.
  • PLC programming, SCADA, Ladder Logic preferred.
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