Job Description

We are seeking a manufacturing/process engineer to enhance and maintain production for medical devices. This role involves collaborating with manufacturing, product development, and quality teams. The engineer will oversee the transfer of products to production and support contract manufacturers in developing and refining processes for critical products within an ISO 13485 framework.

Qualifications: 3+ years of experience in a medical device manufacturing setting.

Technical Skills:

• Facilitate the transition of new or improved products from Engineering to production. This includes a thorough understanding of BOMs, design for manufacturability, process design, process validation, assembly techniques, and design evaluations.
• Skilled in protocol and report creation related to the development of new processes and optimization/validation of existing ones.
• Competent in using SolidWorks for fixture design.
• Ability to read, analyze, interpret, and create engineering drawings.
• Knowledgeable about manufacturing processes, including the fabrication of plastics and metals.
• Assist in the design, selection, and validation of new tooling and equipment.
• Analyze production processes and metrics, such as yield, capacity, and capability.
• Provide technical support for production and quality, employing structured problem-solving methods. Experience in deconstructing high-level performance issues into actionable items.

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