Senior Mechanical Engineer - Rani Therapeutics
San Jose, CA 95173
About the Job
We are seeking an exceptional Senior Mechanical Engineer to design, develop, and validate semi or fully automated equipment that is used for the scale-up of high volume, disposable devices
Your role is to find creative and sound engineering solutions to challenging problems with a strong focus on quality, reliability, and execution
This is a hands-on position that requires interaction and collaboration with a cross-functional team including Engineering, Manufacturing, Biology, Quality, Facilities, and Sustaining.RequirementsDevelop concepts and ideas for improving existing tooling as well as creating new tooling including semi-automation where applicableEvaluate the current manufacturing processes & workflows, identify opportunities for improved performance/throughput by applying knowledge of product design, fabrication, assembly, tooling, and materials as well as soliciting feedback from operatorsTake full ownership of the design, create User Requirements Specification (URS), conduct concept reviews, show proof of concept through prototyping/supporting test data, coordinate with appropriate stakeholders for successful verification/validation, launch, and documentationCreate 3D models, engineering drawings and bills of materialsCreate comprehensive work instructions and manufacturing SOP’sCreate verification/validation protocols (IQ,OQ,PQ), lead/support the execution activities, generate relevant data and provide corresponding documentation and reportsParticipate in design FMEA and plan steps for mitigating risksEstablish a working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordinglyComply with company’s policies and guidelines regarding design control, validation activities and documentation Education and/or Job ExperienceBachelor's Degree in Mechanical Engineering 5-7 years hands-on, relevant experience In-depth experience with complex mechanical/electromechanical designExtensive 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 specificationsDeep knowledge of material properties, heat treatment, and surface finish Proven track record with Medical Device Manufacturing Methods/Procedures, FDA regulations, ISO, cGMP, and QMS standardsGood understanding of DFM and lean manufacturingExcellent verbal, written, presentation and interpersonal skillsStrong analytical and problem-solving skills Knowledge and/or hands-on experience with machine shop toolsDeep knowledge of GD&T as well as proficiency with SolidWorksCreative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasksPreferred QualificationsMaster’s degree in Mechanical Engineering or equivalentKnowledge/experience with plastic injection moldingKnowledge/experience with DOE, SPC, JMP /MinitabExperience with metal stamping, laser cutting and chemical etching Familiarity with and sterilization process and aseptic environment PLC programmingSalary Range: $150,000 - $174,000Rani 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.San Jose, CA /Manufacturing – Manufacturing/Engineering Team /Full Time/ On-site
Your role is to find creative and sound engineering solutions to challenging problems with a strong focus on quality, reliability, and execution
This is a hands-on position that requires interaction and collaboration with a cross-functional team including Engineering, Manufacturing, Biology, Quality, Facilities, and Sustaining.RequirementsDevelop concepts and ideas for improving existing tooling as well as creating new tooling including semi-automation where applicableEvaluate the current manufacturing processes & workflows, identify opportunities for improved performance/throughput by applying knowledge of product design, fabrication, assembly, tooling, and materials as well as soliciting feedback from operatorsTake full ownership of the design, create User Requirements Specification (URS), conduct concept reviews, show proof of concept through prototyping/supporting test data, coordinate with appropriate stakeholders for successful verification/validation, launch, and documentationCreate 3D models, engineering drawings and bills of materialsCreate comprehensive work instructions and manufacturing SOP’sCreate verification/validation protocols (IQ,OQ,PQ), lead/support the execution activities, generate relevant data and provide corresponding documentation and reportsParticipate in design FMEA and plan steps for mitigating risksEstablish a working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordinglyComply with company’s policies and guidelines regarding design control, validation activities and documentation Education and/or Job ExperienceBachelor's Degree in Mechanical Engineering 5-7 years hands-on, relevant experience In-depth experience with complex mechanical/electromechanical designExtensive 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 specificationsDeep knowledge of material properties, heat treatment, and surface finish Proven track record with Medical Device Manufacturing Methods/Procedures, FDA regulations, ISO, cGMP, and QMS standardsGood understanding of DFM and lean manufacturingExcellent verbal, written, presentation and interpersonal skillsStrong analytical and problem-solving skills Knowledge and/or hands-on experience with machine shop toolsDeep knowledge of GD&T as well as proficiency with SolidWorksCreative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasksPreferred QualificationsMaster’s degree in Mechanical Engineering or equivalentKnowledge/experience with plastic injection moldingKnowledge/experience with DOE, SPC, JMP /MinitabExperience with metal stamping, laser cutting and chemical etching Familiarity with and sterilization process and aseptic environment PLC programmingSalary Range: $150,000 - $174,000Rani 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.San Jose, CA /Manufacturing – Manufacturing/Engineering Team /Full Time/ On-site
Source : Rani Therapeutics