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.

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📌 Sr Manufacturing Engineer (Mexicali)
🏢 Intuitive Surgical, S. De R. L De C. V.
📍 Mexicali