Sr Manufacturing Engineer

Intuitive Surgical, S. de R.L de C.V.; Mexicali; Presencial; MXN 650.000 - 850.000; Jornada completa

Descripción de la vacante

Intuitive Surgical, S. de R.L de C.V. is looking for a Design/Manufacturing Engineer in Mexicali, Baja California. The candidate will work on improving designs for low to mid-volume manufacturing lines, analyzing manufacturing risks, and validating processes and equipment.

A Bachelor's degree in Mechanical Engineering is required, along with a minimum of 6 years of experience in the field. Proficiency in CAD software, particularly SolidWorks, is essential. Strong communication skills and the ability to work in a fast-paced environment are crucial for success in this role.

Formación

• Minimum 6 years of experience as design or manufacturing engineer.
• Comfortable with product development lifecycle.
• Ability to execute and document changes in an automated change control system.

Responsabilidades

• Improve existing designs with multidisciplinary teams.
• Support validations including IQ, OQ, PQ.
• Provide technician training and oversee manufacturing stations.

Conocimientos

Mechanical/electromechanical design

CAD (SolidWorks)

SAP transactions

Communication and interpersonal skills

Educación

Bachelor degree in Mechanical Engineering

Master's degree

Descripción del empleo

Responsibilities

• Work within multi-disciplinary teams improving existing designs.
• 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).
• Support Validations(IQ,OQ,PQ)
• 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.

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.
• 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.