Primary Function of Position:
To define and execute the strategy for the Manufacturing Engineering area that
will promote the continuous improvement and support to released production
processes for Instruments and Accessories to ensure reliability, cost,
manufacturability and serviceability.
To manage and coordinate the resources and activities of the Manufacturing
Engineer area and provide mechanical and manufacturing support in accordance
with FDA 21 CFR820 and ISO 13485 standard regulations. Define budget of the
department and execute as planned. This position requires minimal to no
supervision.
Roles & Responsibilities:
• Lead initiatives focused on yield improvement, material cost reduction,
capacity enhancement, and outsourcing of assemblies.
• Evaluate and challenge mechanism designs for process reliability,
serviceability and manufacturability. Provide suggested change proposals.
• Creating budget estimates for tooling, test equipment, prototype designs,
and first article activities.
• Ensure the processes meet the specified requirements for operation
including adherence to parameters, specifications avoiding variations in the
manufacturing process.
• Provides technical support analyzing and /or performing failure analysis for
discrepant production components, assemblies and field returns.
• Qualify, document and introduce production processes.
-Take responsibility for developing and maintaining compliance with the
quality system.
• Evaluate and select suppliers for mechanical parts. Help resolve supplier
quality issues.
• Must possess strong communication skills to interface with suppliers,
product development, planning, purchasing, regulatory, inspection,
customer support and clinical marketing organizations.
• Performs other duties as required.
• Travel: Position may require 5-10% travel, primarily within U.S.
• Drive our Culture Strategy by fostering our mission, founding principles,
individual and leadership expectations.
Skills, Experience, Education, & Training:
Required:
• Candidate must be of high character and energy with regard for detail.
• Demonstrated Mechanical and/or Process Engineering ability.
• Demonstrated ability in failure analysis and continuous improvement.
• BS degree in Mechanical Engineering or equivalent.
• Minimum 3 years manufacturing engineering supervision experience with
Mid/high volume complex manufacturing processes.
Preferred:
• MS degree in an Engineering discipline.
• 3 to 5 years of experience as design or manufacturing engineer supporting
product with significant mechanical/process content.
• Prior experience with various mechanical and or electronics applications
and technologies, including reliability and performance assessment.
• Prior experience working in FDA 21 CFR820/ISO 13485 medical device
manufacturing environment.
• Demonstrate ability to design/execute experiments.
• Prior responsibility for process or product validation/verification.
• Experience with ASME Y14.5 Geometric Dimensioning and Tolerance.
• Experience in Just-In-Time, Demand Flow Technology, and Lean
Manufacturing techniques.
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.
