Primary Function of Position
At Intuitive we believe that minimally invasive care is life-enhancing care. We are looking for team members with exceptional character who have the capacity to simplify complex problems and the energy to urgently deliver solutions to our patients. We use creative techniques to solve hard problems to achieve optimal clinical performance manufacturabilty business objectives and reliability.
Within Intuitive the Single Port robotic platform offers surgeons the ability to perform surgeries through a single incision with boundless possibilities. This Manufacturing Engineer will effectively collaborate with core team partners and individually contribute to sustaining and improving existing manufacturing processes to achieve operational excellence.
Essential Job Duties
- Lead duplication line transfer and operational manufacturing line activities.
- Provide daily engineering support for existing in-house manufacturing lines.
- Execute continuous improvement projects for product quality throughput and cost. Utilize analytical objective data and statistical analysis to establish metrics and to inform goals and priorities.
- Lead root cause investigation and drive dispositions for assembly-related defects.
- Support implementation of design improvements to existing products including:
- Lead Design Verification and Validation (V&V) builds
- Coordinate cut-in/implementation in production
- Design and implement assembly/test fixtures to optimize cycle time repeatability and consistency of complex assembly operations.
- Specify and refine BOMs workflows/travelers and detailed work instructions.
- Collaborate and communicate with cross-functional teams (e.g. Production Design Engineering Quality Engineering Supplier Engineering Project Management) to sustain and optimize processes and line performance.
- Create and revise manufacturing-related validation and risk documents including IQ/OQ/PQ/PPQ protocols Process FMEAs Manufacturing Line Specifications Equipment Specifications.
Qualifications :
Required Skills and Experience
- Strong 3D modeling/CAD experience (SolidWorks preferred)
- Foundation in design fabrication and assembly process development for complex mechanical assemblies.
- Familiarity and experience with the application of lean principles.
- Technical problem-solving skills with the ability to identify root cause and drive corrective action (Fishbone 8D Analysis)
- Demonstrated understanding of component manufacturing processes such as injection molding transfer molding thermoforming machining stamping and MIM.
- Ability to employ statistical methods (Cpk ANOVA Design of Experiments) in data analysis for process development and problem-solving.
- Effective communication skills in Spanish and English (verbal written and presentation) and comfortable interacting with production technicians product design engineers planners buyers clinical engineers and suppliers.
- Able to travel periodically to suppliers or Intuitive manufacturing sites.
Required Education and Training
- Minimum B.S. Mechanical Engineering or related technical discipline; M.S. preferred.
- 8 years with a B.S or 6 years with an M.S. of experience as a process or manufacturing engineer supporting products with significant mechanical content.
- Must be able to travel to the USA 10-15% yearly.
- Able to work in 12-hour day shifts.
- English at a fluent professional level capable of having advanced technical fluid conversations.
- NPI and line transfer experience are required.
- Lean and Six Sigma tools experience.
- Statistical control and statistical analysis are required.
Preferred Skills and Experience
- Experience in mid-volume manufacturing of single-use and reusable medical devices or complex electro-mechanical assemblies is a plus.
- Experience in medical device design controls and manufacturing (ISO 13485) is a plus.
- Machine tool experience is a plus.
Additional Information :
Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados y prohibimos cualquier tipo de discriminacin y acoso independientemente de su raza sexo condicin de embarazo orientacin sexual identidad de gnero origen nacional color edad religin condicin de veterano protegido o de discapacidad informacin gentica o cualquier otra condicin protegida por las leyes federales estatales o locales aplicables.
Remote Work :
No
Employment Type :
Full-time