Manufacturing Engineering Manager

Job DescriptionPrimary 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.

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