Sr Manufacturing Engineer

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

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.
• Lead Design Verification and Validation (V&V) builds
• Coordinate cut-in/implementation in production

Qualifications

Required Skills and Experience

• Foundation in design, fabrication, and assembly process development for complex mechanical assemblies. 
• Six Sigma methodology experienced.
• Strong experience in root cause analysis and other lean tools.
• 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 (bilingual, verbal, written, and presentation) and comfortable interacting with production technicians, product design engineers, planning, buyers, clinical engineers, and suppliers.
• Able to travel periodically to suppliers or Intuitive manufacturing sites.
• Strong 3D modeling/CAD experience (SolidWorks preferred)

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.

Preferred Skills and Experience

• Experience in mid-volume manufacturing of single-use and resposable 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 discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.

Aviso sobre los Controles de Exportación de EE. UU.: De acuerdo con las Regulaciones de Administración de Exportaciones de EE. UU. (15 CFR §743.13(b)), algunos puestos en Intuitive Surgical pueden estar sujetos a controles de exportación de EE. UU. para candidatos que sean nacionales de países actualmente bajo embargo o sanciones.

Cierta información que usted proporcione como parte de la solicitud será utilizada para determinar si Intuitive Surgical necesitará (i) obtener una licencia de exportación del gobierno de EE. UU. en su nombre (nota: el proceso de obtención de la licencia puede tardar entre 3 y más de 6 meses) o (ii) implementar un Plan de Control de Tecnología (“TCP”, por sus siglas en inglés) (nota: normalmente este paso agrega 2 semanas al proceso de contratación).
Para cualquier puesto en Intuitive sujeto a controles de exportación, las ofertas finales están condicionadas a la obtención de una licencia de exportación aprobada y/o a la ejecución de un TCP antes de la fecha de inicio del empleado potencial, la cual puede o no ser flexible, y dentro de un plazo que no obstaculice de manera irrazonable la necesidad de contratación. Si aplica, los candidatos serán notificados e instruidos sobre cualquier requisito relacionado con estos fines.