Purpose of the job

We are seeking a Senior Engineer to support a wide variety of technical activities in a fast-paced environment.  You will lead the research and development activities related to the Rani Therapeutics orally ingestible drug delivery pill.  Research activities include material and/or design optimization and developing specifications and testing requirements to meet design outputs.  This is a hands-on position that requires interaction and collaboration with cross-functional teams including Manufacturing, Process, Quality, and Automation.

 

Major Duties and Responsibilities

  • Lead research and product development activities that result in critical device improvements.
  • Develop tests and experiments that meet external or internal standards for collecting functional data as it relates to product design.  
  • Apply strong analytical skills to identify and understand customer/user needs, market requirements, technical requirements, human factors need, and translation to the finished design output.
  • Collaborate with stakeholders to define and manage product requirements, design specifications, and performance criteria for the device
  • Lead design control activities, technical reviews, and V&V documentation activities within R&D.
  • Conduct risk assessments and lead design reviews to identify and address potential quality issues early in the development process.
  • Mentor a team of multidisciplinary engineers and technicians by providing technical guidance and direction.
  • Identify potential risks and implement mitigation strategies to keep projects on track.
  • Ensure all project activities comply with relevant US/EU regulatory standards and guidelines, are well documented, and are captured in the design history file (DHF).
  • Comply with the company’s quality and regulatory policies and set a standard for excellence.
  • Prepares and presents detailed technical presentations, reports and design documentation as required.
  • Generate intellectual property referenced to the mechanical design  

 

Leadership

  • 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.

 

Education and/or Job Experience

  • Bachelor's Degree in Mechanical Engineering, or Material Science, or related engineering field
  • 5-10 years of hands -on experience in a regulated industry
  • Strong analytical and problem-solving skills
  • In-depth experience with complex mechanical systems
  • Experience with design control process for medical devices and implementation of product in to manufacturing
  • Good understanding of DFM and lean manufacturing
  • Experience with creating engineering drawings, BOMs, and product specifications
  • Excellent verbal, written, presentation and interpersonal skills
  • Deep knowledge of GD&T as well as proficiency with SolidWorks
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
  • Working knowledge of FDA regulations and ISO, cGMP, QMS standards   

 

 

Preferred Qualifications

  • Prior experience in a medical device company
  • Masters’ degree or higher in Mechanical Engineering, Material Science, or related engineering field
  • Knowledge and application of DOE, Statistical Analysis, Minitab experience preferred

 

Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.

Our organization's commitment to Diversity, Equity, and Inclusion is key to making us a better team - one that makes better decisions, drives innovation, and delivers better business results. At Rani Therapeutics, we're committed to a workplace culture where everyone feels comfortable to bring their authentic selves. We pledge to foster inclusion in our organization by promoting psychological safety, embracing differences, and being accountable for our actions. We strive to make Rani a place where each individual feels seen and empowered to reach their highest potential.

Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.