Sr Manufacturing Engineer

Job Description

Primary Function of Position Contribute your technical design and manufacturing skills to a dynamic development team creating systems for minimally invasive robotic surgery. The role requires active participation with new product development teams that create and refine electro-mechanical components and assemblies while challenging new product designs to improve efficacy, reliability, manufacturability, and cost for robotic surgical systems.

Essential Job Duties

• Work within multi-disciplinary teams improving existing designs.
• Refinement of mechanical components and assemblies, with careful consideration for drivetrain components, safety mechanisms and failure contingencies.
• Machined component refinement including considerations for assembly, reliability, cost, and manufacturability.
• Authorship of design documentation for a regulatory controlled environment.
• Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.
• Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability of new products.
• Takes responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation.
• Provides technical support analyzing and /or performing failure analysis for discrepant production components and assemblies.
• Specify, document, procure, qualify, implement, and improve fixtures, hand tools and equipment used in manufacturing.
• Determine, incorporate, and validate critical tests used in manufacturing.

Qualifications

Required Skills and Experience

• Minimum 6 years of experience as design or manufacturing engineer supporting product with significant mechanical/electromechanical content.  Experience with mechanism design refinement, robotics and/or medical products are a plus.
• Comfortable with product development lifecycle including refinement, implementation, debug, verification, qualification, and transfer to manufacturing.
• Ability to execute and document changes in an automated change control system and demonstrate compliance.
• Proficient using CAD (SolidWorks) required.
• Create, maintain, and improve “low to mid-volume” manufacturing lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions.
• Analyze manufacturing line from a risk perspective (pFMEA) to incorporate and validate critical tests used in manufacturing.
• Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/PQ).
• Provide production support of sustaining and startup manufacturing lines.
• Conduct testing of software releases before deploying on manufacturing line
• Provide product and process Design for Manufacturability and Design for Assembly input to enhance manufacturability of new products.
• Maintain all documentation associated with the manufacturing line.
• Conduct SAP transactions relevant to manufacturing operations.
• Provide technician training and oversee specified manufacturing stations to ensure quality.
• Possess strong communication and interpersonal skills used when interfacing with manufacturing, product development, purchasing and inspection resources.
• Self-driven with the ability to excel in a high-energy, small, focused team environment, to maintain a strong sense of shared responsibility and shared reward, and to make work fun and interesting.

Required Education and Training

• Bachelor degree in Mechanical Engineering, Mechatronics or Robotics Engineering.
• Master is a plus

Preferred Skills and Experience  

• Prior responsibility for process, equipment or product validation / verification is a plus.
• Prior experience with complex device manufacturing is a plus.
• Experience in new product introduction/development is desirable.
• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment is desirable.

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.

Este puesto puede cubrirse con un nivel de puesto diferente al indicado aquí, según las necesidades del negocio y/o la experiencia, los conocimientos y las habilidades del candidato o la candidata seleccionado. La compensación se basará principalmente en el nivel del puesto en el que se cubra el rol y en las cualificaciones del candidato o la candidata, de conformidad con la legislación aplicable.